Evaluation of a Rotavirus VaccinePhase 1/2NCT02109484
Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
A Phase 1/2 study testing P2-VP8 Subunit Vaccine 10mcg, P2-VP8 Subunit Vaccine 30 mcg and P2-VP8 Subunit Vaccine 60mcg in people with Evaluation of a Rotavirus Vaccine, run by PATH at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of a Rotavirus Vaccine
- What is being tested?
- P2-VP8 Subunit Vaccine 10mcg, P2-VP8 Subunit Vaccine 30 mcg and P2-VP8 Subunit Vaccine 60mcg
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2014to Nov 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy infants/toddlers as established by medical history and clinical examination before entering study
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Respiratory and Meningeal Pathogens Research Unit (RMPRU)
Johannesburg, Gauteng, 2013
About this study
Official title: 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
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.
- Conditions
- Evaluation of a Rotavirus Vaccine
- Being tested
- P2-VP8 Subunit Vaccine 10mcg, P2-VP8 Subunit Vaccine 30 mcg, P2-VP8 Subunit Vaccine 60mcg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P2-VP8 Subunit Vaccine 10mcgBiological
10 mcg
P2-VP8 Subunit Vaccine 30 mcgBiological
30 mcg
P2-VP8 Subunit Vaccine 60mcgBiological
60 mcg
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort A P2-VP8 30 mcg | Experimental | Cohort A toddlers (24-35 mo) receiving P2-VP8 Subunit Vaccine (30 mcg) Receives: Biological: P2-VP8 Subunit Vaccine 30 mcg |
| Cohort A Placebo | Placebo comparator | Cohort A toddlers (24-35 mo) Receives: Other: Placebo |
| Cohort A P2-VP8 60 mcg | Experimental | Cohort A toddlers (24-35 mo) receiving high dose P2-VP8 Subunit Vaccine (60mcg) Receives: Biological: P2-VP8 Subunit Vaccine 60mcg |
| Cohort B P2-VP8 10mcg | Experimental | Cohort B infants receiving P2-VP8 Subunit Vaccine (10mcg) Receives: Biological: P2-VP8 Subunit Vaccine 10mcg |
| Cohort B placebo | Placebo comparator | Cohort B infants aged 6 to < 8 weeks receiving placebo Receives: Other: Placebo |
| Cohort B P2-VP8 30mcg | Experimental | Cohort B infants aged 6 to < 8 weeks receiving P2-VP8 Subunit Vaccine (30mcg) Receives: Biological: P2-VP8 Subunit Vaccine 30 mcg |
| Cohort B1 P2-VP8 60mcg | Experimental | Cohort B1 Infants aged 6 to < 8 weeks receiving P2-VP8 Subunit Vaccine (60mcg) Receives: Biological: P2-VP8 Subunit Vaccine 60mcg |
| Cohort A P2-VP8 10mcg | Experimental | Cohort A toddlers (24-35 mo) receiving P2VP8 Subunit Vaccine (10mcg) Receives: Biological: P2-VP8 Subunit Vaccine 10mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Vaccine Induced Reactions
Maximum severity of all local reactions or systemic reactogenicity after any vaccination
Measured: 7 days following each dose
Number of Participants With Serious Adverse Events
Number of participants experiencing a Serious Adverse Event within 28 days of a vaccination and at any time during the study
Measured: within 28 days of a study dose and at any time
Number of Participants Reporting Any Non-Serious Adverse Event
all adverse events will be recorded over the duration of the 6 month follow up period.
Measured: 6 mo following first vaccination
Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse.
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.
Measured: Baseline to day 84
Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses
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.
Measured: Baseline to day 84
Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8])
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.
Measured: Baseline to Day 84
Secondary outcomes (1)
Rotavirus Shedding After Administration of Rotarix in Infants Receiving 3 Doses of Vaccine or Placebo.
Percent of infants who shed rotavirus at any timepoint after receiving 3 doses of study vaccine and one dose of Rotarix. Infants received Rotarix vaccination beginning on Day 84. Stool specimens were collected from these infants on the 5th, 7th and 9th day following first administration of Rotarix. This test was performed as a novel functional assessment of the ability to suppress local gut multiplication of the vaccine strain contained in Rotarix.
Measured: Rotarix vaccination on Day 84 to day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Evaluation of a Rotavirus VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Groome, Principal investigator, SAMRC Respiratory and Meningeal Pathogen Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109484
- Sponsor's protocol ID
- VAC-013
- Status last verified
- Nov 2017
- First submitted
- 4 Apr 2014
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32734176Groome 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.
PubMed 28483414
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02109484
- Acronym / sponsor ID
- VAC-013
- Conditions
- Evaluation of a Rotavirus Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort A P2-VP8 30 mcg | Experimental | Biological: P2-VP8 Subunit Vaccine 30 mcgCohort A toddlers (24-35 mo) receiving P2-VP8 Subunit Vaccine (30 mcg) |
| Cohort A Placebo | Placebo comparator | Other: PlaceboCohort A toddlers (24-35 mo) |
| Cohort A P2-VP8 60 mcg | Experimental | Biological: P2-VP8 Subunit Vaccine 60mcgCohort A toddlers (24-35 mo) receiving high dose P2-VP8 Subunit Vaccine (60mcg) |
| Cohort B P2-VP8 10mcg | Experimental | Biological: P2-VP8 Subunit Vaccine 10mcgCohort B infants receiving P2-VP8 Subunit Vaccine (10mcg) |
| Cohort B placebo | Placebo comparator | Other: PlaceboCohort B infants aged 6 to < 8 weeks receiving placebo |
| Cohort B P2-VP8 30mcg | Experimental | Biological: P2-VP8 Subunit Vaccine 30 mcgCohort B infants aged 6 to < 8 weeks receiving P2-VP8 Subunit Vaccine (30mcg) |
| Cohort B1 P2-VP8 60mcg | Experimental | Biological: P2-VP8 Subunit Vaccine 60mcgCohort B1 Infants aged 6 to < 8 weeks receiving P2-VP8 Subunit Vaccine (60mcg) |
| Cohort A P2-VP8 10mcg | Experimental | Biological: P2-VP8 Subunit Vaccine 10mcgCohort A toddlers (24-35 mo) receiving P2VP8 Subunit Vaccine (10mcg) |
Who may qualify
- Ages
- 6 weeks to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- healthy infants/toddlers as established by medical history and clinical examination before entering study
- age:
- parental ability and willingness to provide informed consent
- parental intention to remain in the area with the child during the study period.
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P2-VP8 Subunit Vaccine 10mcg10 mcg | Biological | Cohort A P2-VP8 10mcg, Cohort B P2-VP8 10mcg |
| P2-VP8 Subunit Vaccine 30 mcg30 mcg | Biological | Cohort A P2-VP8 30 mcg, Cohort B P2-VP8 30mcg |
| P2-VP8 Subunit Vaccine 60mcg60 mcg | Biological | Cohort A P2-VP8 60 mcg, Cohort B1 P2-VP8 60mcg |
| Placebo | Other | Cohort A Placebo, Cohort B placebo |
Primary outcome
Number of Participants With Vaccine Induced Reactions
Time frame: 7 days following each dose
Maximum severity of all local reactions or systemic reactogenicity after any vaccination
Number of Participants With Serious Adverse Events
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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])
Time frame: 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.
1 secondary outcome
Rotavirus Shedding After Administration of Rotarix in Infants Receiving 3 Doses of Vaccine or Placebo.
Time frame: Rotarix vaccination on Day 84 to day 91
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32734176Koen 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.
- Derived from this study: PubMed 28483414Groome 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Groome principal investigator
SAMRC Respiratory and Meningeal Pathogen Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing P2-VP8 Subunit Vaccine 10mcg, P2-VP8 Subunit Vaccine 30 mcg and P2-VP8 Subunit Vaccine 60mcg in people with Evaluation of a Rotavirus Vaccine, run by PATH at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Vaccine Induced Reactions (time frame: 7 days following each dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02109484, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.