Phase 2
N=204
Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
Evaluation of a Rotavirus Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT02109484 ↗Enrolled (actual)
204
Serious AEs
9.3%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With Vaccine Induced Reactions — 3; 8; 4; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- P2-VP8 Subunit Vaccine 10mcg (Biological); P2-VP8 Subunit Vaccine 30 mcg (Biological); P2-VP8 Subunit Vaccine 60mcg (Biological); Placebo (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Vaccine Induced Reactions |
3; 8; 4; 6; 6; 2 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants Reporting Any Non-Serious Adverse Event |
2; 7; 6; 8; 41; 11 | — |
| PRIMARY Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse. |
9; 7; 38; 32 | 0.0165 sig |
| PRIMARY Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses |
1; 12; 46; 46; 4; 12 | <0.0001 sig |
| PRIMARY Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8]) |
0; 7; 17; 7; 3; 12 | 0.0004 sig |
| SECONDARY Rotavirus Shedding After Administration of Rotarix in Infants Receiving 3 Doses of Vaccine or Placebo. |
17; 6; 9; 27; 39; 37 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- healthy infants/toddlers as established by medical history and clinical examination before entering study
- age:
- toddler cohort: > or = 2 and or = 6 and <8 weeks at the time of enrollment
- parental ability and willingness to provide informed consent
- parental intention to remain in the area with the child during the study period.
Exclusion Criteria
- Presence of fever on the day of enrollment
- Acute disease at the time of enrollment
- Concurrent participation in another clinical trial throughout the entire timeframe for this study
- Presence of malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination that would compromise the participant's health or is likely to result in nonconformance to the protocol
- For infant cohort, history of premature birth (<37 weeks gestation)
- History of congenital abdominal disorders, intussusception, or abdominal surgery
- Known or suspected impairment of immunological function based on medical history and physical examination
- For infant cohort only, prior receipt of rotavirus vaccine
- A known sensitivity or allergy to any components of the study vaccine
- History of anaphylactic reaction
- Major congenital or genetic defect
- Participant's parents not able, available or willing to accept active weekly follow-up by the study staff
- Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period
- History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study
- Any medical condition in the parents/infant that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent
- HIV infection
- For toddlers, to be assessed by HIV ELISA
- For infants, to be assessed by PCR, if mother is not known to be negative (negative test result between 24 weeks gestation and screening)
Data sourced from ClinicalTrials.gov (NCT02109484). 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.