Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
NCT ID: NCT02109484
Last Updated: 2017-12-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
204 participants
INTERVENTIONAL
2014-03-31
2015-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A P2-VP8 30 mcg
Cohort A toddlers (24-35 mo) receiving P2-VP8 Subunit Vaccine (30 mcg)
P2-VP8 Subunit Vaccine 30 mcg
30 mcg
Cohort A Placebo
Cohort A toddlers (24-35 mo)
Placebo
Cohort A P2-VP8 60 mcg
Cohort A toddlers (24-35 mo) receiving high dose P2-VP8 Subunit Vaccine (60mcg)
P2-VP8 Subunit Vaccine 60mcg
60 mcg
Cohort B P2-VP8 10mcg
Cohort B infants receiving P2-VP8 Subunit Vaccine (10mcg)
P2-VP8 Subunit Vaccine 10mcg
10 mcg
Cohort B placebo
Cohort B infants aged 6 to \< 8 weeks receiving placebo
Placebo
Cohort B P2-VP8 30mcg
Cohort B infants aged 6 to \< 8 weeks receiving P2-VP8 Subunit Vaccine (30mcg)
P2-VP8 Subunit Vaccine 30 mcg
30 mcg
Cohort B1 P2-VP8 60mcg
Cohort B1 Infants aged 6 to \< 8 weeks receiving P2-VP8 Subunit Vaccine (60mcg)
P2-VP8 Subunit Vaccine 60mcg
60 mcg
Cohort A P2-VP8 10mcg
Cohort A toddlers (24-35 mo) receiving P2VP8 Subunit Vaccine (10mcg)
P2-VP8 Subunit Vaccine 10mcg
10 mcg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
P2-VP8 Subunit Vaccine 10mcg
10 mcg
P2-VP8 Subunit Vaccine 30 mcg
30 mcg
P2-VP8 Subunit Vaccine 60mcg
60 mcg
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age:
* toddler cohort: \> or = 2 and \<3 years old at the time of enrollment
* infant cohort: \> 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
* 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)
6 Weeks
35 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PATH
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michelle Groome
Role: PRINCIPAL_INVESTIGATOR
SAMRC Respiratory and Meningeal Pathogen Research Unit
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Respiratory and Meningeal Pathogens Research Unit (RMPRU)
Johannesburg, Gauteng, South Africa
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Koen A, Jose L, Madhi SA, Fix A, Cryz S, Groome MJ. Neutrophil Counts in Healthy South African Infants: Implications for Enrollment and Adverse Event Grading in Clinical Trials in an African Setting. J Pediatr X. 2019 Spring;1:100005. doi: 10.1016/j.ympdx.2019.100005.
Groome MJ, Koen A, Fix A, Page N, Jose L, Madhi SA, McNeal M, Dally L, Cho I, Power M, Flores J, Cryz S. Safety and immunogenicity of a parenteral P2-VP8-P[8] subunit rotavirus vaccine in toddlers and infants in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2017 Aug;17(8):843-853. doi: 10.1016/S1473-3099(17)30242-6. Epub 2017 May 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VAC-013
Identifier Type: -
Identifier Source: org_study_id
NCT02132156
Identifier Type: -
Identifier Source: nct_alias