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

NCT01148459 | Completed Phase 3 Results

• 1 other identifier: 112745
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Conditions

Malaria

Keywords

Plasmodium falciparum; schedule; HIV; malaria vaccine; EPI; Africa

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Serious Adverse Events (SAEs)

  SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  During the entire study period (from 30 days before Dose 1 up to Month 14)

Secondary Outcomes (18)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)

• Number of Subjects With Any Unsolicited Adverse Events (AEs)

  During the 30-day post-vaccination period (up to Day 90)

• Number of Subjects With Non-malaria Related SAEs

  During the entire study period (from 30 days before vaccine Dose 1 up to Month 14)

• Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations

  Prior to vaccination (PRE) and one month post Dose 3 (Month 3)

Study Arms (2)

Group A

EXPERIMENTAL

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

Biological: GSK Biological's Investigational Malaria Vaccine 257049

Group B

ACTIVE COMPARATOR

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

Biological: Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);; Biological: Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).

Interventions

GSK Biological's Investigational Malaria Vaccine 257049 BIOLOGICAL

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

Group A

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

Group B

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

Group B

Eligibility Criteria

• Age: 6 Weeks - 17 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Kisian, Kenya

Location

GSK Investigational Site

Kisumu, Kenya

Location

Related Publications (1)

• 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.

  PMID: 27394191 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Rabies Vaccines; lactitol

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 22, 2010
• Study Start: July 30, 2010
• Primary Completion: May 24, 2013
• Study Completion: May 24, 2013
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

KE (2)