A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00263666

Purpose

The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' 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.

Condition	Intervention	Phase
Rotavirus Gastroenteritis	Biological: Rotarix Biological: Placebo Biological: TritanrixTM-HB+Hib Biological: SabinPolioTM vaccine	Phase II

MedlinePlus related topics: AIDS Gastroenteritis

Drug Information available for: RotaTeq

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	Assess the Safety, Reactogenicity and Immunogenicity of 3 Doses of GSK Biologicals' HRV Vaccine Administered to HIV Infected Infants at 6, 10 and 14 Weeks of Age in South Africa.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of grade "2" or grade "3" fever, vomiting or diarrhea [ Time Frame: Within the 15-day solicited follow-up period after any doses. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of unsolicited symptoms. [ Time Frame: Within 30 days after each dose ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events. [ Time Frame: Throughout the study period ] [ Designated as safety issue: Yes ]
CD4 count and CD4 percent. [ Time Frame: At the screening visit and Visit 4 ] [ Designated as safety issue: No ]
HIV Viral load [ Time Frame: At the screening visit and Visit 4 ] [ Designated as safety issue: No ]
Seroconversion rate against rotavirus [ Time Frame: Two months after the 3rd dose of vaccine/ placebo ] [ Designated as safety issue: No ]
Vaccine take rate (seroconversion or Rotavirus vaccine antigen excretion) [ Time Frame: Two months after the 3rd dose of vaccine/ placebo ] [ Designated as safety issue: No ]
Serum rotavirus IgA antibody titres. [ Time Frame: Two months after the 3rd dose of vaccine/ placebo ] [ Designated as safety issue: No ]
anti-PRP antibody concentrations more than or equal to the cut-off value [ Time Frame: Two months after the 3rd dose of routine TritanrixTM-HB+Hib + PolioSabinTM vaccines ] [ Designated as safety issue: No ]
anti-diphtheria toxoid antibody concentrations more than or equal to the cut-off value [ Time Frame: Two months after the 3rd dose of routine TritanrixTM-HB+Hib + PolioSabinTM vaccines ] [ Designated as safety issue: No ]
anti-tetanus toxoid antibody concentrations more than or equal to the cut-off value [ Time Frame: Two months after the 3rd dose of routine TritanrixTM-HB+Hib + PolioSabinTM vaccines ] [ Designated as safety issue: No ]
anti-HBs antibody concentrations more than or equal to the cut-off value [ Time Frame: Two months after the 3rd dose of routine TritanrixTM-HB+Hib + PolioSabinTM vaccines ] [ Designated as safety issue: No ]
For each type of solicited symptoms, occurrence of the symptom. [ Time Frame: Within the 15-day solicited follow-up period after each dose ] [ Designated as safety issue: Yes ]
anti-BPT antibody concentrations more than or equal to the cut-off value [ Time Frame: Two months after the 3rd dose of routine TritanrixTM-HB+Hib + PolioSabinTM vaccines ] [ Designated as safety issue: No ]
GMC/Ts for anti-PRP, anti-diphtheria and anti-tetanus toxoids, anti-BPT, anti-HBs and anti-polio types 1, 2 and 3 antibodies. [ Time Frame: Two months after the 3rd dose of routine TritanrixTM-HB+Hib + PolioSabinTM vaccines ] [ Designated as safety issue: No ]
RV antigen excretion in stool samples [ Time Frame: At day of each vaccination and at planned days following each vaccine dose ] [ Designated as safety issue: No ]
Rotavirus in diarrheal stool samples [ Time Frame: For diarrhea episodes from Visits 1 to 4 ] [ Designated as safety issue: No ]
RV vaccine identification if applicable. [ Time Frame: For diarrhea episodes from Visits 1 to 4 ] [ Designated as safety issue: No ]
Enteric pathogens identification. [ Time Frame: For diarrhea episodes from Visits 1 to 4 ] [ Designated as safety issue: No ]
anti-polio types 1, 2 and 3 antibody concentrations more than or equal to the cut-off value [ Time Frame: Two months after the 3rd dose of routine TritanrixTM-HB+Hib + PolioSabinTM vaccines ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	March 2005
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HRV Group: Experimental	Biological: Rotarix Oral vaccination Biological: TritanrixTM-HB+Hib Concomitant routine vaccination, IM administration Biological: SabinPolioTM vaccine Oral administration, concomitant routine vaccination
Placebo Group: Placebo Comparator	Biological: Placebo Oral administration Biological: TritanrixTM-HB+Hib Concomitant routine vaccination, IM administration Biological: SabinPolioTM vaccine Oral administration, concomitant routine vaccination

Detailed Description:

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 vaccinations will be administered concomitantly with the study vaccines. This study will evaluate safety, reactogenicity and immunogenicity of the HRV vaccine relative to the placebo.

Eligibility

Ages Eligible for Study:	6 Weeks to 10 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263666

Locations

South Africa
GSK Investigational Site
Brits, South Africa, 0250
GSK Investigational Site
Ga-Rankuwa, South Africa, 0208
GSK Investigational Site
Pretoria, South Africa, 0084
South Africa, Gauteng
GSK Investigational Site
Attridgerville, Gauteng, South Africa, 0008
South Africa, North-West
GSK Investigational Site
Garankuwa, North-West, South Africa, 0204

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications indexed to this study:

Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M; Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	444563/022
Study First Received:	December 8, 2005
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00263666
Health Authority:	South Africa: Medicines Control Council

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Gastroenteritis

ClinicalTrials.gov processed this record on January 16, 2009