Phase 2
N=618
Safety and Immunogenicity Study of Trivalent P2-VP8 Subunit Rotavirus Vaccine in Adults, Toddlers and Infants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02646891 ↗Enrolled (actual)
618
Serious AEs
6.0%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Trivalent P2-VP8 Subunit Rotavirus Vaccine (Biological); Placebo (Biological)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination |
1; 7; 9; 2; 6; 2 | — |
| PRIMARY Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen |
16; 131; 130; 134; 38; 131 | — |
| PRIMARY Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen |
13; 35; 40; 32; 13; 37 | — |
| PRIMARY Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain |
26; 96; 107; 105; 26; 100 | — |
| PRIMARY Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen |
73; 80; 62; 76; 30; 1456 | — |
| PRIMARY Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen |
5; 5; 5; 5; 6; 9 | — |
| PRIMARY Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants |
118; 154; 128; 130; 42; 90 | — |
| SECONDARY Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period |
2; 8; 11; 5; 9; 8 | — |
| SECONDARY Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen |
7; 126; 121; 131; 25; 136 | — |
| SECONDARY Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen |
6; 22; 29; 20; 12; 22 | — |
| SECONDARY Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination |
16; 49; 51; 49; 19; 38 | — |
| SECONDARY Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen |
0; 11; 11; 0; 7; 11 | — |
| SECONDARY Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen |
0; 11; 11; 0; 8; 11 | — |
| SECONDARY Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain |
0; 3; 8; 0; 1; 5 | — |
| SECONDARY Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen |
425; 358; 444; 183; 195; 282 | — |
| SECONDARY Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen |
151; 186; 143; 174; 124; 49 | — |
| SECONDARY Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers |
317; 448; 276; 77; 131; 67 | — |
Summary
This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study examined the safety and immunogenicity of three dose levels of this vaccine in healthy South African adults, toddlers and infants. Progression from one dose level to another and to the next age group population was based on the assessment of safety information from the lowest dose and older age group.
The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated. The primary immunogenicity hypothesis is that the trivalent P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response to at least 2 of the 3 strains in 60% or more of participants in at least one of the study groups.
Eligibility Criteria
Inclusion Criteria
- Healthy adults (≥ 18 and ≤ 45 years), toddlers (≥ 2 and ≤ 3 years), and infants (≥ 6 and ≤ 8 weeks)
- Participants will remain in the area during the study
- Females of childbearing potential must not be pregnant or breastfeeding, and willing to use adequate method of contraception during the trial.
Exclusion Criteria
- Presence of fever or other acute illness
- concurrent participation in another clinical trial
- Presence of malnutrition or other systemic disorder.
- Infants with history of premature birth (< 37 week gestational age)
- History of congenital abdominal disorders or surgery
- Suspected or known impairment of immune function
- Infants who have received rotavirus vaccine in the past
- Known sensitivity to any components of the vaccine
- History of anaphylactic reaction
- Major congenital or genetic defect
- Unwillingness to follow study schedule
- Receipt of immunoglobulin therapy or blood products in last 6 months
- History of chronic immunosuppressive medications (with the exception of inhaled or topical steroids)
- Any medical condition that, in the judgement of the investigator, would interfere with the protocol, or would interfere with participant's ability to adhere to the study protocol.
- Clinically significant screening laboratory value
- Human immunodeficiency virus (HIV) infection
Data sourced from ClinicalTrials.gov (NCT02646891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.