A phase II, double-blind, randomised, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Dr Duncan Steele

ORCID ID

Contact details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)227913752
steeled@who.int

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

NCT00263666

Protocol/serial number

444563-022

Scientific title

A phase II, double-blind, randomised, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa

Acronym

Rota022

Study hypothesis

The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' HRV vaccine given concomitantly with routine vaccines including Oral Poliomyelitis Vaccine (OPV) in HIV positive infants.

Ethics approval(s)

Ethics approval received in 2004.

Study design

Phase II double-blind randomised placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Vaccine/immunisation

Intervention

Intervention: three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration
Control: placebo

Intervention type

Biological/Vaccine

Pharmaceutical study type(s)

Phase

Phase II

Drug/device/biological/vaccine name(s)

Primary outcome measure

Percentage of subjects who report grade "2" or grade "3" fever, vomiting or diarrhoea during the 15-day f/u period after each dose.

Secondary outcome measures

1. Reactogenicity
2. Serious adverse events (SAEs)
3. CD4 count and human immunodeficiency virus (HIV) viral load at screening and visit 4
4. Immunogenicity
5. Rotavirus shedding until ceases
6. Enteric pathogens
7. Immunogenicity of antigens contained in concomitantly administered routine vaccine DTPw-HBV/Hib + OPV

Overall study start date

01/01/2004

Overall study end date

01/01/2006

Reason abandoned (if study stopped)

Participant inclusion criteria

1. Parents/guardians of subjects who could comply with the protocol requirements (e.g. completion of diary cards, return for follow-up visits)
2. Male or female 6 - 10 weeks of age at the time of first vaccination
3. Written informed consent from parents/guardians
4. Documented HIV status of the subject as confirmed by Polymerase Chain Reaction (PCR)
5. HIV asymptomatic and HIV mildly symptomatic
6. Categories N and A according to CDC HIV clinical classification
7. Born after a gestation period of 36 - 42 weeks

Participant type(s)

Patient

Age group

Child

Lower age limit

6 Weeks

Upper age limit

10 Weeks

Sex

Both

Target number of participants

100

Participant exclusion criteria

1. Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period
2. Previous routine vaccination except Bacillus Calmette-Guerin (BCG) and hepatits B virus (HBV)
3. Clinically significant history of chronic gastrointestinal tract (GIT) disease including any incorrected congenital malformation of GIT
4. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine
5. Acute illness at the time of enrolement
6. Diarrhea with in 7 days preceding the study vaccination
7. Administration of immunoglobulins and/or blood products since birth or planned during study period
8. Use of any investigational or non-registered drug or vaccine other than study vaccines during the study period

Recruitment start date

01/01/2004

Recruitment end date

01/01/2006

Countries of recruitment

South Africa, Switzerland

Study participating centre

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Organisation

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

Sponsor details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

ROR

https://ror.org/01f80g185

Funder type

Research organisation

Funder name

RAPID trials (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Health Organization (WHO) (Switzerland)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location

Switzerland

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs