Phase I/II Descending Age Double-blinded Randomized Placebo-controlled Dose Escalation Study to Examine the Safety Reactogenicity Tolerability & Immunogenicity of the P2-VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers & Infants

NCT02109484 Phase 1/Phase 2 COMPLETED Results posted

This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers. If the safety profile is deemed appropriate, the study will continue to explore the safety and immunogenicity of the vaccine in healthy South African infants. The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is that the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response in at least 80% of participants in at least one of the study groups.

Details

Lead sponsor	PATH
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	204
Start date	2014-03
Completion	2015-11

Conditions

• Evaluation of a Rotavirus Vaccine

Interventions

• P2-VP8 Subunit Vaccine 10mcg
• P2-VP8 Subunit Vaccine 30 mcg
• P2-VP8 Subunit Vaccine 60mcg
• Placebo

Primary outcomes

• Number of Participants With Vaccine Induced Reactions — 7 days following each dose
  Maximum severity of all local reactions or systemic reactogenicity after any vaccination
• Number of Participants With Serious Adverse Events — within 28 days of a study dose and at any time
  Number of participants experiencing a Serious Adverse Event within 28 days of a vaccination and at any time during the study
• Number of Participants Reporting Any Non-Serious Adverse Event — 6 mo following first vaccination
  all adverse events will be recorded over the duration of the 6 month follow up period.
• Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse. — Baseline to day 84
  Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third vaccination). Confidence intervals are displayed as percentages.
• Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses — Baseline to day 84
  Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third injection).An unadjusted serioresponse was defined as an increase of 4 times or more in titers between baseline and 4 weeks after the 3rd injection. Adjusted IgG and neutralizing antibody post injection titres accounted for the decay in maternal antibodies using the half-life calculated from participants in the placebo group with detectable baseline titers higher than those at the post injection visit.
• Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8]) — Baseline to Day 84
  Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third injection).An unadjusted serioresponse was defined as an increase of 4 times or more in titers between baseline and 4 weeks after the 3rd injection. Adjusted IgG and neutralizing antibody post injection titres accounted for the decay in maternal antibodies using the half-life calculated from participants in the placebo group with detectable baseline titers higher than those at the post injection visit.

Countries

South Africa