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Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants

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ClinicalTrials.gov Identifier: NCT02109484
Recruitment Status : Completed
First Posted : April 10, 2014
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
PATH

Brief 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.


Condition or disease Intervention/treatment Phase
Evaluation of a Rotavirus Vaccine Biological: P2-VP8 Subunit Vaccine 10mcg Biological: P2-VP8 Subunit Vaccine 30 mcg Biological: P2-VP8 Subunit Vaccine 60mcg Other: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : March 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Cohort A P2-VP8 30 mcg
Cohort A toddlers (24-35 mo) receiving P2-VP8 Subunit Vaccine (30 mcg)
Biological: P2-VP8 Subunit Vaccine 30 mcg
30 mcg

Placebo Comparator: Cohort A Placebo
Cohort A toddlers (24-35 mo)
Other: Placebo
Experimental: Cohort A P2-VP8 60 mcg
Cohort A toddlers (24-35 mo) receiving high dose P2-VP8 Subunit Vaccine (60mcg)
Biological: P2-VP8 Subunit Vaccine 60mcg
60 mcg

Experimental: Cohort B P2-VP8 10mcg
Cohort B infants receiving P2-VP8 Subunit Vaccine (10mcg)
Biological: P2-VP8 Subunit Vaccine 10mcg
10 mcg

Placebo Comparator: Cohort B placebo
Cohort B infants aged 6 to < 8 weeks receiving placebo
Other: Placebo
Experimental: Cohort B P2-VP8 30mcg
Cohort B infants aged 6 to < 8 weeks receiving P2-VP8 Subunit Vaccine (30mcg)
Biological: P2-VP8 Subunit Vaccine 30 mcg
30 mcg

Experimental: Cohort B1 P2-VP8 60mcg
Cohort B1 Infants aged 6 to < 8 weeks receiving P2-VP8 Subunit Vaccine (60mcg)
Biological: P2-VP8 Subunit Vaccine 60mcg
60 mcg

Experimental: Cohort A P2-VP8 10mcg
Cohort A toddlers (24-35 mo) receiving P2VP8 Subunit Vaccine (10mcg)
Biological: P2-VP8 Subunit Vaccine 10mcg
10 mcg




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   6 Weeks to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109484


Locations
South Africa
Respiratory and Meningeal Pathogens Research Unit (RMPRU)
Johannesburg, Gauteng, South Africa, 2013
Sponsors and Collaborators
PATH
Investigators
Principal Investigator: Michelle Groome SAMRC Respiratory and Meningeal Pathogen Research Unit

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02109484     History of Changes
Obsolete Identifiers: NCT02132156
Other Study ID Numbers: VAC-013
First Posted: April 10, 2014    Key Record Dates
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs