Contact information
Type
Scientific
Primary contact
Dr Roland Sutter
ORCID ID
Contact details
World Health Organization
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 4682
sutterr@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC236
Study information
Scientific title
Acronym
Study hypothesis
The study aims to demonstrate the superiority of one dose of monovalent type 1 Oral Poliovirus Vaccine (mOPV1) or monovalent type 3 Oral Poliovirus Vaccine (mOPV3) compared to trivalent Oral Poliovirus Vaccine (tOPV) in inducing seroconversion.
Ethics approval
Ethics approval received from:
1. World Health Organization (WHO) Ethics Review Committee (ERC) on the 24th October 2007 (ref: RPC236)
2. University of Cape Town's Research Ethics Committee on the 2nd October 2007 (ref: 355/2007)
Regulatory authority approval from the Medicines Control Council South Africa is still in progress.
Study design
Interventional randomised double blind controlled trial for 3 arms of vaccine produced by GSK but randomised and unblinded for the mOPV1 vaccine produced by Panacea Biotec Ltd.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Poliomyelitis
Intervention
Control group:
2 drops (approximately 0.1 ml) standard dose of tOPV manufactured by GlaxoSmithKline (GSK) at birth.
Intervention groups:
1. 2 drops (approximately 0.1 ml) of mOPV1 manufactured by GSK at birth
2. 2 drops (approximately 0.1 ml) of mOPV1 manufactured by Panacea at birth
3. 2 drops (approximately 0.1 ml) of mOPV3 manufactured by GSK at birth
Blood collection at birth (cord blood or blood from newborn) and at 30 days.
Principal Investigator:
Professor Gregory D. Hussey
Institute of Infectious Disease and Molecular Medicine
University of Cape Town
Anzio Road, Observatory
7925 Cape Town
South Africa
Tel: +27 (0)21 406 6738
Fax: +27 (0)21 406 6081
Email: Gregory.Hussey@uct.ac.za
Intervention type
Drug
Phase
Not Specified
Drug names
Monovalent type 1 Oral Poliovirus Vaccine (mOPV1), monovalent type 3 Oral Poliovirus Vaccine (mOPV3), trivalent Oral Poliovirus Vaccine (tOPV)
Primary outcome measure
Seroconversion 30 days after a single dose of tOPV, mOPV1, or mOPV3. Measurements on humoral immunity (specific primary endpoints) as as follows:
1. One dose of mOPV1 induces significantly higher levels of seroconversion against poliovirus type 1 than one dose of tOPV
2. One dose of mOPV3 induces significantly higher levels of seroconversion against poliovirus type 3 than one dose of tOPV
Secondary outcome measures
No secondary outcome measures
Overall trial start date
15/11/2007
Overall trial end date
15/11/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy infants (birth weight greater than or equal to 2.5 kg and Apgar score greater than or equal to 9 at 5 minutes) born at study sites
2. Residing less than or equal to 50 km from study sites
3. Family is not planning on travel during the study period (birth to 1 month)
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
800
Participant exclusion criteria
1. High risk newborns
2. Other newborns requiring hospitalisation
3. Birthweight less than 2.5 kg
4. Apgar score less than 9 at 5 minutes
5. Infants residing more than 50 km from study sites
6. Infants whose families are planning to be absent during one month study period
7. A diagnosis or suspicion of B cell immunodeficiency in participant or immediate family
The study will not collect information on acquired immunodefiency disease or Human Immunodeficiency Virus (HIV) status of mother or study subject.
Recruitment start date
15/11/2007
Recruitment end date
15/11/2009
Locations
Countries of recruitment
South Africa
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO) (Switzerland)
Sponsor details
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 4682
sutterr@who.int
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO) (Switzerland)
Alternative name(s)
WHO
Funding Body Type
unknown
Funding Body Subtype
Location
Funder name
Gates Foundation (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
International Financing Facility for Immunisations (IFFIm) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22158680
Publication citations
-
Results
Waggie Z, Geldenhuys H, Sutter RW, Jacks M, Mulenga H, Mahomed H, De Kock M, Hanekom W, Pallansch MA, Kahn AL, Burton AH, Sreevatsava M, Hussey G, Randomized trial of type 1 and type 3 oral monovalent poliovirus vaccines in newborns in Africa., J. Infect. Dis., 2012, 205, 2, 228-236, doi: 10.1093/infdis/jir721.