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

NCT00263666 | Completed Phase 2 Results

• 2 other identifiers: 444563/0222015-001484-39
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Infections, Rotavirus

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (23)

• Number of Subjects Reporting Any Unsolicited Symptoms

  Within 30 days after any dose

• Number of Subjects Reporting Any Serious Adverse Events

  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

  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

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

• Human Immunodeficiency Virus (HIV) Viral Load

  At the screening visit and 2 months after dose 3

Study Arms (2)

Rotarix Group

EXPERIMENTAL

Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.

Biological: Rotarix; Biological: Tritanrix-HB+Hib; Biological: Polio Sabin

Placebo Group

PLACEBO COMPARATOR

Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.

Biological: Placebo; Biological: Tritanrix-HB+Hib; Biological: Polio Sabin

Interventions

Rotarix BIOLOGICAL

Oral vaccination

Rotarix Group

Placebo BIOLOGICAL

Oral administration

Placebo Group

Tritanrix-HB+Hib BIOLOGICAL

Concomitant routine vaccination, IM administration

Placebo Group; Rotarix Group

Polio Sabin BIOLOGICAL

Oral administration, concomitant routine vaccination

Placebo Group; Rotarix Group

Eligibility Criteria

• Age: 6 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Attridgerville, Gauteng, 0008, South Africa

Location

GSK Investigational Site

Coronationville, Gauteng, 2112, South Africa

Location

GSK Investigational Site

Garankuwa, North West, 0204, South Africa

Location

GSK Investigational Site

Brits, 0250, South Africa

Location

GSK Investigational Site

Capital Park, 0002, South Africa

Location

GSK Investigational Site

Ga-Rankuwa, 0208, South Africa

Location

Related Publications (3)

• Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.

  PMID: 24047799 BACKGROUND

• Steele AD, Madhi SA, Louw CE, Bos P, Tumbo JM, Werner CM, Bicer C, De Vos B, Delem A, Han HH. Safety, Reactogenicity, and Immunogenicity of Human Rotavirus Vaccine RIX4414 in Human Immunodeficiency Virus-positive Infants in South Africa. Pediatr Infect Dis J. 2011 Feb;30(2):125-30. doi: 10.1097/INF.0b013e3181f42db9.

  PMID: 20842070 BACKGROUND

• 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. doi: 10.1056/NEJMoa052434.

  PMID: 16394298 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

Rotavirus Infections

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was conducted in a double-blind manner. The parents/guardians of the subjects and the study personnel were unaware of the administered treatment (HRV vaccine or placebo).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2005
• First Posted: December 9, 2005
• Study Start: March 16, 2005
• Primary Completion: February 7, 2008
• Study Completion: February 13, 2008
• Last Updated: November 23, 2020
• Results First Posted: March 13, 2009

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

ZA (6)