A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa

GlaxoSmithKline100 enrolled

Overview

The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

HIV infected infants as determined prior to study entry (screening) and asymptomatic or mildly symptomatic (WHO stages I and II) of disease will be enrolled. The study will have two groups: Group HRV and Group Placebo. Three-dose immunisation will be administered at approximately 6, 10, and 14 weeks of age. Routine EPI (Expanded Program on Immunisation) vaccinations will be administered concomitantly with the study vaccines. At the time of first dose, subjects will be aged 6 to 10 weeks. This study will evaluate safety, reactogenicity and immunogenicity of the HRV vaccine relative to the placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Infections, Rotavirus

Interventions

RotarixBIOLOGICAL

Oral vaccination

PlaceboBIOLOGICAL

Oral administration

Tritanrix-HB+HibBIOLOGICAL

Concomitant routine vaccination, IM administration

Polio Sabin

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 10 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including 6 and 10 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parents or guardians of the subject * Documented HIV status of the subject as confirmed by PCR. * HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children. * Born after a gestation period of 36 to 42 weeks. Exclusion Criteria: * Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Previous routine vaccination except OPV, BCG and HBV vaccination at birth * Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator. * History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. * Acute disease at time of enrolment. * Gastroenteritis within 7 days preceding the study vaccine administration. * Previous confirmed occurrence of RV gastroenteritis. * Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes. * HIV moderately and severely symptomatic: stages III and IV according to WHO's recent classification. * Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.

Locations (6)

GSK Investigational Site

Attridgerville, Gauteng, South Africa

GSK Investigational Site

Coronationville, Gauteng, South Africa

GSK Investigational Site

Garankuwa, North West, South Africa

GSK Investigational Site

Brits, South Africa

Outcomes

Primary Outcomes

Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea

Symptoms reported in the table include: Fever: temperature (axillary route) \> 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day.

Time frame: Within the 15-day solicited follow-up period after any dose

Secondary Outcomes

Number of Subjects Reporting Any Unsolicited Symptoms

An unsolicited symptom was any spontaneously reported untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time frame: Within 30 days after any dose

Number of Subjects Reporting Any Serious Adverse Events

A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Time frame: Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3)

Number of Subjects Reporting Each Type of Solicited Symptom

Solicited symptoms included Cough, Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5°C), Irritability, Loss of appetite, and Vomiting.

Time frame: Within the 15-day solicited follow-up period after each dose

The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent

Severe suppression: CD4+ cells/microliter (μl) \< 750 and CD4+ percent \< 15 percent (%); No evidence of suppression: CD4+ cells/μl ≥ 1500 and CD4+ percent ≥ 25%; Moderate suppression = all other CD4+ cell count and CD4+ % combinations.

Data from ClinicalTrials.gov

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Oral administration, concomitant routine vaccination

GSK Investigational Site

Capital Park, South Africa

GSK Investigational Site

Ga-Rankuwa, South Africa

Time frame: At the screening visit and 2 months after dose 3 (Visit 4)

Human Immunodeficiency Virus (HIV) Viral Load

The HIV viral load was expressed as mean and standard deviation of the base-10 logarithm of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL).

Time frame: At the screening visit and 2 months after dose 3

Number of Subjects Who Seroconverted Against Rotavirus

A subject with anti-rotavirus Immunoglobulin (IgA) antibody concentration \< 20 units/milliliter (U/mL) before vaccination and ≥ 20 U/mL after vaccination is considered as seroconverted.