Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children

NCT ID: NCT01148459

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-30
• Study Completion Date: 2013-05-24

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in HIV-infected infants and children

Detailed Description

This protocol posting has been updated due to protocol Amendment 2.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Infants enrolled to this group will receive 3 doses of the experimental vaccine.

Group Type: EXPERIMENTAL

GSK Biological's Investigational Malaria Vaccine 257049

Intervention Type: BIOLOGICAL

All infants enrolled to group A will receive 3 doses of the experimental vaccine. The vaccine will be administered intramuscularly.

Group B

Infants enrolled to this group will receive 3 doses of the rabies comparator vaccine.

Group Type: ACTIVE_COMPARATOR

Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);

Intervention Type: BIOLOGICAL

To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product.

The vaccine will be administered intramuscularly

Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).

Intervention Type: BIOLOGICAL

To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product.

The vaccine will be administered intramuscularly.

Interventions

GSK Biological's Investigational Malaria Vaccine 257049

All infants enrolled to group A will receive 3 doses of the experimental vaccine. The vaccine will be administered intramuscularly.

Intervention Type: BIOLOGICAL

Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);

To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product.

The vaccine will be administered intramuscularly

Intervention Type: BIOLOGICAL

Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).

To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product.

The vaccine will be administered intramuscularly.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

All subjects must satisfy ALL the following criteria at study entry:

• A male or female infant or child between and including 6 weeks to 17 months of age, at the time of first vaccination.
• Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the infant or child. Where parents/LARs are illiterate, the consent form will be countersigned by a witness.
• Subjects who the investigator believes that their parents/LARs can and will comply with the requirements of the protocol should be enrolled in the study.
• Subjects who are known to be HIV-infected (documented positive DNA PCR), whether taking HIV antiretroviral treatment (ART) or not.
• Subjects who are born following a normal gestation period.

Exclusion Criteria

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• Acute disease at the time of enrolment. However, the presence of an illness listed as Grade I or Grade II (WHO pediatric AIDS clinical staging) will not of itself constitute an exclusion criterion. Enrolment should be deferred if axillary temperature is >=37.5°C.
• Grade III or Grade IV abnormality on screening laboratory blood sample.
• Grade III or IV AIDS at the time of enrolment (WHO pediatric AIDS clinical staging).
• Major congenital defects.
• Planned administration/administration of a vaccine not foreseen by the study protocol prior to or within 7 days of study vaccine.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding Dose°1 of study vaccine, or planned use during the study period.
• Previous participation in any other malaria vaccine trial.
• Simultaneous participation in another clinical trial including administration of experimental treatment.
• Same sex twins.
• History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
• History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
• Child in care.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 17 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Kisian, , Kenya

GSK Investigational Site

Kisumu, , Kenya

Countries

Kenya

References

Otieno L, Oneko M, Otieno W, Abuodha J, Owino E, Odero C, Mendoza YG, Andagalu B, Awino N, Ivinson K, Heerwegh D, Otsyula N, Oziemkowska M, Usuf EA, Otieno A, Otieno K, Leboulleux D, Leach A, Oyieko J, Slutsker L, Lievens M, Cowden J, Lapierre D, Kariuki S, Ogutu B, Vekemans J, Hamel MJ. Safety and immunogenicity of RTS,S/AS01 malaria vaccine in infants and children with WHO stage 1 or 2 HIV disease: a randomised, double-blind, controlled trial. Lancet Infect Dis. 2016 Oct;16(10):1134-1144. doi: 10.1016/S1473-3099(16)30161-X. Epub 2016 Jul 7.

Reference Type: DERIVED

PMID: 27394191 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

112745

Identifier Type: -

Identifier Source: org_study_id