RV144 is an HIV vaccine candidate that combines two different vaccine types: a prime and a booster.
The Prime recombinant is a canarypox vector vaccine (ALVAC-HIV).
The booster component, AIDSVAX, is a recombinant glycoprotein 120 subunit vaccine
RV144 is indicated to prevent HIV.
This prime and boost combination was tested in a clinical trial in Thailand.
February 18, 2015: An HIV vaccine clinical trial (called HVTN-100) in South Africa was announced by the U.S. National Institutes of Allergy & Infectious Diseases (NIAID) division of the National Institutes of Health (NIH).
This clinical trial includes Sanofi Pasteur’s ALVAC-HIV investigational vaccine along with the adjuvanted protein vaccine supplied by GSK.
December 3, 2009: Results of the Clinical Trial NCT00223080:
In the intention-to-treat analysis involving 16,402 subjects, there was a trend toward the prevention of HIV-1 infection among the vaccine recipients, with a vaccine efficacy of 26.4% (95% confidence interval [CI], −4.0 to 47.9; P=0.08). I
n the per-protocol analysis involving 12,542 subjects, the vaccine efficacy was 26.2% (95% CI, −13.3 to 51.9; P=0.16). I
n the modified intention-to-treat analysis involving 16,395 subjects (with the exclusion of 7 subjects who were found to have had HIV-1 infection at baseline), the vaccine efficacy was 31.2% (95% CI, 1.1 to 52.1; P=0.04).
Clinical Trial NCT02968849: Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa (HVTN702)
- This study will evaluate the preventive vaccine efficacy, safety, and tolerability of the ALVAC-HIV vaccine from Sanofi Pasteur + Bivalent Subtype C gp120 protein adjuvanted with MF59 from GSK in HIV-seronegative South African adults over 24 months from enrollment.
- Participants will be randomized to receive ALVAC-HIV (vCP2438), or placebo, by intramuscular injection at weeks 0 and 4; they will receive ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59, or placebo, by IM injection at weeks 12, 24, and 52.
- In addition to the vaccination visits, participants will attend study visits at weeks 26, 39, 54, 65, 78, 91, 104, 117, 130, 142, and 156.
- All study visits, including vaccination visits, will include HIV risk reduction counseling, a physical exam, and an interview/questionnaire. and pregnancy testing for participants capable of becoming pregnant.
- Select study visits will include a medical history review, physical exam, blood collection, urine collection, HIV testing, and pregnancy testing for participants capable of becoming pregnant.
Clinical Trial NCT00223080: HIV Vaccine Trial in Thai Adults
- A vaccine for the prevention of HIV infection remains an urgent need as part of the efforts to control the HIV pandemic.
- In this phase III efficacy trial, a 'prime-boost' vaccine strategy is evaluated for the prevention of infection and amelioration of disease course.
- ALVAC-HIV from Sanofi Pasteur is given as the 'prime' vaccine at months 0, 1, 3 and 6; AIDSVAX gp120 B/E from VaxGen is given as the 'boost' at months 3 and 6.
- This regimen will be given to 8,000 adult Thai subjects, while another 8,000 will be given placebos in a double-blinded, randomized manner.
- Following the completion of each subject's immunization phase, he/she will be followed for 3 years with clinic visits every 6 months with HIV testing, pre- and post-test counseling.
- Subjects who become HIV infected will be counseled, referred to HIV treatment facilities for management according to national guidelines, and offered enrollment in a protocol for extended follow-up.