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Sputnik Light Vaccine

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Last reviewed
May 12, 2022
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Sputnik Light Vaccine Description

The Sputnik Light single-dose recombinant human adenovirus 26 serotypes (rAd26) COVID-19 vaccine is based on a proven and well-studied platform of human adenoviral vectors that cause the common cold and have been around for thousands of years, as demonstrated by the Russian Gamaleya Center during laboratory tests. 

Adenoviruses are found in the respiratory tract and cause acute respiratory infections, which have become a commonly used virus to engineer vectors. Gamaleya Center scientists have worked with adenoviral vector-based vaccines since the 1980s and are leaders in developing these vaccines.

The effectiveness of Sputnik Light was found 79.4% based on the analysis of data from the 28th day after receiving immunization by citizens of the Russian Federation as part of the mass vaccination program in the period December 5, 2020 - to April 15, 2021. Furthermore, the Sputnik Light vaccine developed virus-neutralizing antibodies in 91.67% of individuals on the 28th-day post-immunization. And the cellular immune response against the S Protein of SARS-CoV-2 develops in 100% of volunteers on the 10th day.

On May 6, 2021, the Ministry of Health of the Russian Federation, the National Research Center for Epidemiology and Microbiology, and the Russian Direct Investment Fund (RDIF) announced the single-component Sputnik Light vaccine registration. Sputnik Light international clinical trials included people from Moscow, Russia, Ghana, the United Arab Emirates, and other countries.

Immunizing individuals with pre-existing immunity against the SARS-CoV-2 virus with Sputnik Light can increase antigen-specific IgG antibodies by more than 40x in 100% of subjects ten days after immunization. On May 24, 2021, the RDIF announced data from a study conducted by the Institute of Virology of the National University of Cordoba (Argentina) and the authorities of Cordoba, which confirmed 85.5% of individuals developed IgG antibodies to the SARS-CoV-2 coronavirus on the 14th day after receiving the first injection of Sputnik V.

A Gamaleya Center analysis announced on October 13, 2021, found the vaccine is more than 75% effective among subjects under 60. In addition, Sputnik Light also provides much higher efficacy against severe disease and hospitalizations. The analysis was based on data from 28,000 participants who had received a single dose of Sputnik Light, compared with a control group of 5.6 million individuals who were not vaccinated. The data used in the study was collected in July 2021 in Moscow.

The Lancet Europe published a study that conducted an open-label, prospective, non-randomized phase 1/2 clinical trial to assess the safety, tolerability, and immunogenicity of the "Sputnik Light" vaccine in a single center in Russia on November 2, 2021. Results Interpretation - The single-dose rAd26 vector-based Sputnik Light vaccine has a good safety profile and induces strong humoral and cellular immune responses in seronegative and seropositive participants.

The Russian sovereign wealth fund (RDIF), based in Moscow, was established in 2011. In addition, the Federal Government Budgetary Institution, "National Research Center for Epidemiology and Microbiology," is one of Russia's oldest scientific research centers and celebrated its 100th anniversary in 1991.

Sputnik Light Vaccine Indication

Sputnik Light is indicated to build immunity to SARS-CoV-2, which causes COVID-19 disease. The RDIF announced on June 2, 2021, that the Sputnik Light vaccine demonstrated 78.6-83.7% efficacy among the elderly, according to real-world data collected by the Ministry of Health of the Buenos Aires province. According to the data from Argentina, over 186,000 people aged 60-79, more than 40,000 of whom received a shot of Sputnik Light, the infection rate between the 21st and 40th day from the date of receiving the first dose was only 0.446%.

On June 6, 2021, the journal Nature published an article: Mounting evidence suggests Sputnik COVID vaccine is safe and effective. In conclusion, 'Several other studies are currently underway in countries that have approved Sputnik, including Argentina, Venezuela, Russia, and Turkey, which should help build a more accurate picture of the vaccine's safety and efficacy.' In particular, data from the Ministry of Health of the Buenos Aires province (Argentina) shows 78.6-83.7% efficacy among the elderly. And in Paraguay, Sputnik Light is 93.5% effective during the ongoing vaccination campaign, according to the country's Ministry of Health.

Data from a non-peer-reviewed study published on December 23, 2021, show that vaccination with Sputnik V and revaccination with Sputnik Light induces a robust neutralizing antibody response. The Philippines began using Sputnik Light as a 'booster' on January 28, 2022.

Sputnik Light Effectiveness Against the Omicron Variant

As of May 5, 2022, the U.S. NIH's OpenData portal evaluates the Sputnik V vaccine's in vitro effectiveness against SARS-CoV-2 virus variants, such as Omicron. A small preliminary laboratory study published on January 19, 2022, has shown that Omicron-neutralising antibodies of people vaccinated with Russia's Sputnik V vaccine did not decline as much as mRNA vaccines.

A non-peer-reviewed study published on December 21, 2021, found neutralizing antibodies in the blood serum of people vaccinated with Sputnik V, as well as those revaccinated with Sputnik Light after Sputnik V. Results showed that a decrease in the level of neutralizing antibodies was observed against SARS-CoV-2 Omicron (B.1.1.529) variant in comparison to B.1.1.1 variant. Analysis of the sera of individuals vaccinated with Sputnik V 6-12 months ago showed a decrease in neutralizing antibodies by 11.76 folds. While no direct comparison with other COVID-19 vaccine declines has been made in this study, we note their reported reduction in antibody neutralization at a much more significant level of 40-84 times. At the same time, the analysis of sera of individuals vaccinated with Sputnik V and then revaccinated Sputnik Light showed that 2-3 months after vaccination, the decrease in the level of neutralizing antibodies against the Omicron variant was 7.13 folds. Despite the decrease in NtAb, we showed that all revaccinated individuals had NtAb to Omicron variant. Moreover, the NtAb level to Omicron variant in revaccinated sera is slightly higher than NtAb to B.1.1.1 in vaccinated sera.

Sputnik Light Vaccine Dosage

Sputnik Light is the first component (recombinant human adenovirus 26 serotype (rAd26) of the Sputnik V vaccine, which was Approved in Russia in August 2020. It is manufactured as a liquid formulation containing 10¹¹ vp per 0·5 mL/dose. For intramuscular injection Composition for one dose (0.5 ml): Active substance: recombinant serotype 26 adenoviral particles containing the SARS-CoV-2 S protein gene, in the amount of (1.0±0.5) x 10*11 particles per dose.

Sputnik Light Adverse Events

As of July 18, 2021, no serious adverse events were registered after vaccination with Sputnik Light. In addition, real-world vaccination data in Serbia on May 28, 2021, confirmed no vaccine-related severe adverse events. Furthermore, the Ministry of Health of the Province of Buenos Aires, Brazil, reported on July 30, 2021, according to the preliminary results of the ongoing investigation, the safety study on the combinations of the Sputnik V vaccines with Sinopharm and with AstraZeneca vaccines did not report any serious adverse events.

On August 18, 2021, the Sputnik Light vaccine was found highly effective against COVID-19 among more than 320,000 subjects who had received the vaccine based on the data collected by Paraguay's Ministry of Health, July 30, 2021. 

Sputnik Light Vaccine Cost

The cost of the Sputnik Light vaccine could be less than $10, while it has simple storage requirements, at +2 +8, which provides for easy logistics.

Sputnik Light and AZD2816 Co-Development

The RDIF announced interim results of the trials on February 14, 2022, involving 100 volunteers in Russia and 100 volunteers in Azerbaijan; the Sputnik Light and AZD2816 vaccine combination demonstrated an acceptable safety profile. Volunteers receive intramuscular injections of the AstraZeneca vaccine and the Ad26-S component of the Sputnik V vaccine in different sequences at 28-day intervals. The research in Azerbaijan began in February 2021. In addition to Azerbaijan, a clinical study of a combination of vaccines within a global program is being implemented in the United Arab Emirates and Russia. 

Sputnik Light Vaccine Availability

As of May 12, 2022, the Sputnik Light vaccine was authorized as a standalone vaccine and a universal booster in over (30) countries: Russia, Venezuela, Angola, Bahrain, Nicaragua, PalestineMauritiusArgentina, AzerbaijanBelarus, Republic of Congo, MongoliaKyrgyz Republic, South KoreaKazakhstan, Syrian Arab Republic, IndiaPhilippines, Armenia, Iran, Egypt, Libya, UAE, Cambodia, San Marino, LaoSaint Vincent and the Grenadines, Turkmenistan, Tunisia, Morocco, Hungary, Vietnam, India, and the Republic of Benin.

Sputnik Light Vaccine News

May 7, 2022 - Local media reported Dr Reddy’s Laboratories started discussions with the manufacturing partners, hospitals, and also with the Indian government to make the Sputnik Light vaccine an option on the CoWIN platform.

April 30, 2022 - India's National Technical Advisory Group on Immunisation recommended that the Sputnik Light vaccine be taken as a precaution.

April 18, 2022 - TASS reported Belarusian Health Minister Dmitry Pinevich presented the Belarusian-made Sputnik Light vaccine to prevent COVID-19.

April 9, 2022 - Prof. Alexander Gintsburg head of Gamaleya Center, tells TASS. “XE is a combined variant of BA.1 and BA.2, and Sputnik is effective against both. Sputnik Light and nasal form of the vaccine will be effective vs. Omicron XE.

March 21, 2022 - Hetero Biopharma received approval from India's Central Drugs Standard Control Organisation to manufacture and sell Sputnik Light for restricted emergency use in India.

March 20, 2022 - A. Gintsburg, the Gamaleya Center head, Tweeted on Sputnik nasal vaccine: “It has been tested against #Omicron variant, and it works." The Gamaleya Center submitted the documents for the nasal form of Sputnik vaccine authorization to the Health Ministry. Authorization is expected shortly.

March 5, 2022 - India's local media reported, "The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation recommended granting permission for the phase-3 clinical trial with Sputnik Light."

February 21, 2022 - The RDIF announced regulatory authorities of China had approved the mixing of domestic inactivated vaccines against COVID (Sinovac and Sinopharm). While China's State Council has authorized mix & match boosting only with domestic vaccines, the Russian one-shot Sputnik Light vaccine (the first component of Sputnik V) can become a solution for boosting those initially vaccinated with Chinese vaccines in other countries around the world.

February 17, 2022 - The EMA stated: Findings confirm a vaccination strategy where different COVID19 vaccines are used for the primary vaccination and the booster is safe and effective.'

February 14, 2022 - Irina Panarina, GM, Russia & Eurasia, stated in an RDIF press release, 'The results, obtained in the clinical trials, indicate the safety of vaccine combination. The use of «vaccine cocktails» may be an option in the face of the growing healthcare system's need to vaccinate population across the world.'

February 6, 2022 - India's Dr. @mansukhmandviya tweeted the 'DCGI has granted emergency use permission to the Sputnik Light vaccine. This is the 9th COVID-19 vaccine authorized in India. A preliminary study by the Gamaleya Center found a Sputnik Light booster significantly increases virus-neutralizing activity against Omicron.

February 4, 2022 - The Sputnik V vaccine was granted full Approval by Russia's Health Ministry. It had previously held temporary emergency use authorization.

February 1, 2022 - Bloomberg Twwted: Hungarian PM Viktor Orban says Hungary to buy one-shot Sputnik Light Covid vaccine.

January 31, 2022 - Media in Italy reported Sputnik Light vaccination reservations will start in February 2022. A third dose 'booster', which for the so-called "vaccine tourists". An opportunity for San Marino on the tourism front, observes the Secretary of Tourism Pedini Amati.

January 28, 2022 - Dr Reddy's submitted a proposal to India's regulator for using the Sputnik Light vaccine as a booster dose for other COVID-19 vaccines.

January 28, 2022 - The Philippines the Department of Health confirmed the single-dose Sputnik Light vaccine can now be used as a booster shot for different types of COVID vaccine.

January 24, 2022 - Local media reported the Sputnik Light has been given to 90,972 people as a 3rd shot. There are 150 vaccination sites in the Turkestan region.

January 18, 2022 - Alexander Gintsburg, Gamaleya Center head on Sputnik's efficacy against Omicron Tweeted: "In the general population, the efficacy of the Sputnik V vaccine against Omicron stands at 75% and significantly increases with Sputnik Light booster in 6 months."

January 14, 2022 - TASS reported the Ministry of Health of the Republic of Benin approved the Sputnik Light vaccine.

January 12, 2022 - TASS reported 150,000 doses of the Sputnik Light vaccine have been delivered to Kazakhstan.

January 7, 2022 - Reuters reported Hungary has received a shipment of the Sputnik Light vaccine for assessment by the Hungarian health authorities.

December 29, 2021 - The RDIF announced the approval of the Sputnik Light vaccine as a universal booster shot by Tunisia's Ministry of Health.

December 25, 2021 - Turkmenistan's ministry said in a statement that it registered the Sputnik Light vaccine and issued a corresponding certificate for its use, reported AA.com.TR.

December 21, 2021 - The RDIF announced 7 million doses of Sputnik Light booster had been shipped to Venezuela, becoming the most extensive one-time global delivery of the one-shot vaccine.

December 17, 2021 - The Gamaleya Center demonstrated that the Sputnik V vaccine and the one-shot Sputnik Light booster (human adenovirus serotype 26, the first component of Sputnik V) are effective against the Omicron (B.1.1.529) variant of the SARS.CoV-2 coronavirus.

December 7, 2021 - The European Medicines Agency and the ECDC announced the heterologous vaccinations could be used for both initial vaccination courses and boosters, providing for better immunity against coronavirus.

December 6, 2021 - The Ministry of Health of Argentina has approved the Sputnik Light vaccine.

December 1, 2021 - The RDIF, Vabiotech, and the Sovico investment group signed a cooperation agreement to manufacture the Sputnik Light vaccine in Vietnam.

November 30, 2021 - The RDIF announced the UAE's Ministry of Health and Prevention approved Sputnik Light as a booster for all adults and can be used six months after receiving the second component of any vaccines used in the UAE vaccination program.

November 23, 2021 - The RDIF announced that the Governments had approved the Sputnik Light vaccine of the Republic of San Marino and the Lao People's Democratic Republic.

November 21, 2021 - ANI reported the Russian President Putin received a third COVID-19 vaccination with the Sputnik Light vaccine.

November 19, 2021 - The Russian government donated 5,000 doses of the Sputnik Light vaccine to the Philippines.

November 16, 2021 - The Philippines' Food and Drug Administration amended the emergency use authorization of the Sputnik Light vaccine, "meaning six months after the second dose, another dose can be administered."

November 14, 2021 - UNI reported revaccinations with Sputnik Light vaccine might be required every six months.

November 13, 2021 - An intranasal vaccine developed by the Gamaleya National Research Center for Epidemiology and Microbiology can be used for revaccination combined with the Sputnik Light vaccine in the future, the Center's Director Alexander Gintsburg told TASS.

November 8, 2021 - South Korea-based Prestige Biopharma confirmed it had received a technology transfer from Human Vaccine (HV) and ENSO Healthcare DMCC to manufacture the Sputnik Light vaccine. HV holds a license for undertaking the manufacture and sale of the Sputnik vaccine, and ENSO is RDIF's coordination partner for sourcing and distributing the Sputnik vaccine.

November 3, 2021 - Reuters reported the Sputnik Light vaccine had a good safety profile and induced robust immune responses, especially in people who had already encountered COVID-19.

November 2, 2021 - The Lancet Europe published the findings from a phase 1/2 study with the involvement of 6,000 participants (4,500 subjects in the vaccine group and 1,500 in the placebo group) would help to investigate further whether a single-dose "Sputnik Light" vaccine could be a good choice for revaccination providing effective protection from SARS-CoV-2 infection in persons with pre-existing immunity.

November 1, 2021 - Reuters reported that spokesman Dmitry Peskov said, "Therefore, Sputnik Light can be used both as the main vaccine and a booster."

October 31, 2021 - The RDIF announced that the Kingdom of Cambodia had registered Sputnik V and Sputnik Light vaccines.

October 21, 2021 - The Russian Direct Investment Fund reiterates that the heterologous boosting approach pioneered by Sputnik V Light strengthens and lengthens immune response, increases vaccine efficacy against new mutations, and provides flexibility to vaccination efforts worldwide.

October 15, 2021 - The NEJM published a Correspondence' Differential Kinetics of Immune Responses Elicited by Covid-19 Vaccines.' These data show differential kinetics of immune responses induced by the mRNA and Ad26.COV2.S vaccines over an 8-month follow-up period.

October 14, 2021 - The RDIF announced interim results of the study in Argentina on heterogeneous regimens combining the Sputnik Light vaccine and vaccines produced by AstraZeneca, Sinopharm, Moderna, and Cansino. Each" "vaccine cocktail" combination with Sputnik Light provided higher antibody titer on the 14th day after administering the second dose as compared to the original homogenous (same vaccine as first and second dose) regimens of each of the vaccines; the data also demonstrated a high safety profile of using Sputnik Light in combinations with all other vaccines with no serious adverse events following the vaccination in any combinations; the study provides the most substantial scientific evidence to date supporting the mix&match approach with five vaccines involved.

October 13, 2021 - The Russian Direct Investment Fund and Gamaleya National Research Center of Epidemiology and Microbiology announced the results of an efficacy analysis of the one-shot Sputnik Light vaccine against infection from the Delta variant. The article states that the Sputnik Light vaccine administered alone has demonstrated 70% efficacy against infection from the Delta variant of coronavirus during the first three months after vaccination. In addition, the vaccine is 75% effective among subjects under the age of 60.

October 10, 2021 - Indian drug firm Hetero Biopharma Limited has been allowed to export 40 lakh doses of Sputnik Light to Russia, sources in the know of the developments told PTI.

October 6, 2021 - The RDIF announced the Ministry had approved the single-component Sputnik Light vaccine of Health and Prevention of the UAE.

September 27, 2021 - The RDIF, UK-based AstraZeneca, and R-Pharm announce preliminary virus-neutralizing activity results of combined use of the AstraZeneca COVID-19 vaccine and the first component of the Sputnik V vaccine (human adenovirus serotype 26) obtained during the clinical trial in the Republic of Azerbaijan.

September 26, 2021 - A non-peer-reviewed cohort study: SARS-CoV-2 vaccines breakthrough infection hospitalizations after one dose in Libya. These researchers concluded," We found that one dose of the three different types of vaccines had decreased the virus transmission across people and mortality rate until ten weeks after the first dose."

September 24, 2021 - The RDIF announced the Egyptian Drug Authority had approved the single-component Sputnik Light vaccine.

September 17, 2021 - According to local media, vaccine czar Carlito Galvez, Jr. confirmed that the Philippines would receive the first Sputnik Light vaccines in September 2021.

September 15, 2021 - Local media reported the Drugs Controller General of India had approved Sputnik Light to conduct the bridging phase 3 clinical trials in India.

September 14, 2021 - Reuters reported GL Rapha, based in South Korea, expects regulatory Approval to export about 10 million Sputnik Light vaccines during September 2021. GL is awaiting a Good Manufacturing Practice review for its production facility. In November 2020, the Russian Direct Investment Fund and GL Rapha announced a vaccine production agreement.

September 12, 2021 - EClinincalMedicine / The Lancet published a news study: Effectiveness of the first component of Gam-COVID-Vac (Sputnik V) on reducing SARS-CoV-2 confirmed infections, hospitalizations, and mortality in patients aged 60-79: a retrospective cohort study in Argentina. During the study period, 415,995 registered subjects received the first component of Gam-COVID-Vac; 40387 belonged to the 60-79 age group and were compared to 38,978 unvaccinated. Vaccine effectiveness for preventing laboratory-confirmed infections was 78•6% [CI95% 74·8 - 81·7]; and for reducing hospitalizations and deaths was, respectively, 87·6% [CI95% 80·3 - 92·2] and 84·8% [CI95% 75·0 - 90·7]. Effectiveness was high across all subgroups.

September 3, 2021 - A non-peer-reviewed study concluded Sputnik V vaccination was effective against referral to hospital in patients with symptomatic SARS-CoV-2 infection in St. Petersburg, Russia. This protection is probably mediated through VE against lung injury associated with COVID-19.

August 23, 2021 - A non-peer-review study found the Sputnik V vaccine offers strong protection against hospitalization. This protection was probably mediated through vaccine effectiveness against lung injury associated with COVID-19.

August 20, 2021 - The Russian Direct Investment Fund, AstraZeneca, and R-Pharm announced preliminary results on the immunogenicity of combined use of the AstraZeneca vaccine known as Vaxzevria and the Sputnik Light vaccine based on human adenovirus serotype 26 from the clinical trial of vaccines combination in the Republic of Azerbaijan. To date, 64 volunteers have been vaccinated, the enrollment of volunteers is ongoing. Preliminary data from the first 20 participants show antibodies to the SARS-CoV-2 virus spike protein elicited in 100% of cases.

August 18, 2021 - The RDIF announced the data fromParaguay'ss Ministry of Health on the one-shot Sputnik Light vaccine demonstrated a high safety profile and a 93.5% efficacy against COVID-19 among more than 320,000 subjects who had received the vaccine, based on the data collected by July 30, 2021.

August 4, 2021 - The Russian Direct Investment Fund announced the initial safety results of the randomized, single-blind study for the evaluation of the immune response and safety of heterogeneous regimens combining the Sputnik Light vaccine and vaccines produced by AstraZeneca, Sinopharm, and Moderna in the Buenos Aires province of Argentina. The data of 121 volunteers corresponding to the Sputnik V combination groups were analyzed in the following regimens: Sputnik Light/AstraZeneca, Sputnik Light/Moderna, Sputnik Light/Sinopharm, Sputnik Light/Sputnik Light compared to control group Sputnik V 1 Comp./Sputnik V 2 Comp. The data collected by the Ministry of Health of Buenos Aires demonstrates that both the combination of Sputnik Light with other vaccines and vaccination with two injections of only Sputnik Light shows a high safety profile with no serious adverse events following the vaccination. Furthermore, all of the combinations studied are safe, stated the press release.

July 30, 2021 - The RDIF and partners announced they would publish initial data in August 2021 on the immunogenicity of the combined use of the AstraZeneca vaccine and the first component of the Sputnik V vaccine Azerbaijan. Clinical trials of vaccines are being carried out in several countries as part of a global program. Volunteers are being vaccinated in UAE, and regulatory Approval to conduct trials has been granted in Russia and Belarus.

July 24, 2021 - TASS reported Russia delivered a batch of Sputnik Light vaccines to Syria, an official with the Russian Defense Ministry told reporters.

July 9, 2021 - A new study based on Argentina's data found that 21 days after receiving the first dose of vaccine, 94% of naïve participants developed spike-specific IgG antibodies. A single Sputnik V dose elicits higher antibody levels and virus-neutralizing capacity in previously infected individuals than in naïve ones receiving the full two-dose schedule. After a single dose in naïve participants, the high seroconversion rate suggests a benefit of delaying second dose administration to increase the number of people vaccinated. 

July 7, 2021 - Korea Biomedical Review announced Huons Global said that it had secured an exclusive right for the domestic licensing and sales of the Sputnik Light vaccine from the Russian Direct Investment Fund.

June 30, 2021 - India's Subject Expert Committee (SEC) deliberated on the submission for Marketing Authorisation of the Sputnik Light vaccine from Dr. Reddy's." The SEC also observed that because of the safety and immunogenicity data already generated by Dr. Reddy'ss in India on the first dose component of the Sputnik V vaccine, there was no need for a separate Phase III trial of Sputnik Light in India" Dr. Reddy's said in a statement.

June 21, 2021 - TASS reported the first batches of the Sputnik Light vaccine would enter Russia's civilian circulation after June 25, 2021.

June 2, 2021 - The RDIF announced data from the Ministry of Health of the province of Buenos Aires, Argentina, which demonstrated the high efficiency of the Sputnik Light vaccine at the level of 78.6-83.7% when vaccinating the elderly. According to the analysis of data, more than 186 thousand people aged 60 to 79 years, more than 40 thousand of whom received an injection of the "Sputnik Ligh" vaccine during the mass vaccination of the population, the SARS-CoV-2 virus incidence in the period from 21 to 40 days after receiving one injection was only 0.446%. On the other hand, the incidence among the unvaccinated adult population for the same period was 2.74%.

May 24, 2021 - A study conducted by the Institute of Virology of the National University of Cordoba located in Argentina and the authorities of Cordoba confirmed 14 days after receiving the first injection of Sputnik V, 85.5% of individuals developed SARS-CoV-2 coronavirus IgG antibodies.

May 6, 2021 - The effectiveness of the single-component vaccine" "Sputnik Ligh" was 79.4% based on the analysis of data from the 28th day after receiving immunization by citizens of the Russian Federation as part of the mass vaccination program in the period December 5, 2020 - April 15, 2021. An efficacy rate of about 80% exceeds that of many vaccines requiring two shots.

Sputnik Light Vaccine Clinical Trials

Sputnik Light is undergoing several clinical trials.