ZPIV is a Zika virus vaccine candidate which consists of a purified formalin-inactivated Zika virus.
ZPIV is indicated to prevent Zika transmission.
ZPIV in these clinical trials were given as intramuscular injections on days 1 and 29.
In all 3 studies, healthy adults were randomly assigned by a computer-generated list to receive 5 μg ZPIV or saline placebo, in a ratio of 4:1 at Walter Reed Army Institute of Research, Silver Spring, MD, USA, or of 5:1 at Saint Louis University, Saint Louis, MO, USA, and Beth Israel Deaconess Medical Center, Boston, MA, USA.
The primary objective was the safety and immunogenicity of the ZPIV candidate.
Clinical Trial NCT02963909: A Phase 1, First-in-human, Double-blinded, Randomized, Placebo-controlled Trial of a Zika Virus Purified Inactivated Vaccine (ZPIV) With Alum Adjuvant in Healthy Flavivirus-naive and Flavivirus-Primed Subjects
This Phase 1 study is to evaluate two doses of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) administered 28 days apart.
- The study will enroll 75 flavivirus naïve healthy adult subjects into 3 equal groups sequentially.
- Each group will include 20 ZPIV recipients and 5 placebo recipients.
- Group 1 will receive two ZPIV or placebo doses 28 days apart. Those in Group 1 who consent to a third ZPIV dose will receive 5.0 mcg dose of ZPIV or placebo administered IM on Day 224.
- Group 2 subjects will receive a two-dose regimen of IXIARO® 28 days apart; two ZPIV or placebo doses three months later 28 days apart. Those in Group 2 who consent to a third ZPIV dose will receive it on Day 336.
- Group 3 subjects will receive one dose of YF-VAX® followed three months later by two ZPIV or placebo doses 28 days apart. Those in Group 3 who consent to a third ZPIV dose will receive it on Day 308. In each group, those who do not agree to receive the third ZPIV dose will be followed based on the schedule.
The primary objectives of this study are:
- To evaluate the safety and reactogenicity of a two-dose homologous prime-boost regimen of ZPIV among flavivirus-naïve, YF-VAX® primed, and IXIARO® primed subjects
- To evaluate the safety and reactogenicity of a third dose of ZPIV in consenting subjects.
Clinical Trial NCT02952833: ZIKA Vaccine in Naive Subjects
- This study is to evaluate the safety of ZPIV.
- Three dose levels may be evaluated.
- The entire duration of each subject's participation is approximately 14 months including recruitment and collection of data on the safety and reactogenicity of the study vaccine and samples for the assessment of immunogenicity.
- This study is expected to take approximately 30 months to complete from initiation through the availability of a final report on the primary outcomes of safety and the secondary outcomes of humoral immunity to ZIKV.
The Primary objectives of this study are:
- Assess the safety and reactogenicity of a homologous prime-boost regimen of ZPIV given at three different dose levels
- Compare the safety and reactogenicity profile of ZPIV after each vaccination and between dosage groups.
Clinical Trial NCT02937233: Zika Virus Purified Inactivated Vaccine (ZPIV) Accelerated Vaccination Schedule Study (Z001)
- This is a phase 1 trial of one or more administrations of Zika Virus Purified Inactivated Vaccine (ZPIV).
- The trial will be conducted under a placebo-controlled, double-blind, randomized allocation of study product.
- There are four groups in the study. Each group is testing a different vaccine schedule.