Contact information
Type
Scientific
Primary contact
Dr Marie-Pierre Preziosi
ORCID ID
Contact details
Initiative for Vaccine Research
World Health Organization (WHO)
Department of Immunisation
Vaccines and Biologicals (IVB)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3744
preziosim@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC217; PsA-TT-003
Study information
Scientific title
Acronym
Study hypothesis
To compare the immunogenicity of a single dose of the PsA-TT vaccine with that of the Meningococcal A component of the PsACWY vaccine at 28 days after vaccination.
Ethics approval
Ethics approval received from:
1. The Gambia Government/Medical Research Council (MRC) Laboratories Joint Ethic Committee on the 30th July 2007 (ref: L2007.56)
2. Ethics committee of the National Center for Scientific Research (Centre National de la Recherche Scientifique [CNRS]) on the 8th August 2007 (ref: 127MSPM/DS/CNRS)
3. Ethics committee of the Faculty of Medicine Pharmacy and Odonto-stomatology (Faculte de Medecine de Pharmacie et d'Odonto-Stomatologie [FMPOS]) on the 23rd July 2007 (ref: 0750/FMPOS)
Study design
Phase II/III, observer-blind, randomised, active controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Bacterial meningitis
Intervention
1. One 0.5 ml dose out of a decadose vial of PsA-TT vaccine will be injected intramuscularly (IM) in the right deltoid
2. One 0.5 ml dose of PsACWY vaccine will be injected IM in the right deltoid
Joint sponsor:
Program for Appropriate Technology in Health (PATH) (USA)
1455 NW Leary Way
Seattle
WA 98107
U.S.A.
Tel: +1 206 285 3500
Fax: +1 206 285 6619
Principal Investigators:
Dr Samba Sow (PI for Mali)
Centre pour les Vaccins en Developpement (CVD) Mali
Centre National d'Appui a la lutte contre la Maladie (CNAM)
Ministere de la Sante
Ex-Institut Marchoux
BP 251 Bamako
Mali
Tel: +223 (0)674 8947
Fax: +223 (0)222 2883
Email: ssow@medicine.umaryland.edu
Dr Brown Okoko (PI for The Gambia)
Medical Research Council (MRC) Laboratories
PO Box 273
Fajara
The Gambia
Tel: +220 (0)779 2510
Fax: +220 (0)449 6513
Email: bokoko@mrc.gm
Dr Aldiouma Diallo (PI for Senegal)
Institut de Recherche pour le Développement (IRD)
BP 1386
CP 18524 Dakar
Senegal
Tel: +220 (0)654 1333
Email: diallo@ird.sn
Intervention type
Drug
Phase
Phase II/III
Drug names
Meningococcal A conjugate vaccine (PsA-TT), meningococcal ACWY polysaccharide vaccine
Primary outcome measures
The percentage of subjects who show a seroconversion for anti-Meningococcal Polysaccharide A (MenPsA) antibodies, i.e. a four-fold increase in post-immunisation serum titre with respect to pre-immunisation serum titre, at 28 days after a single vaccine dose, as measured by rabbit complement Serum Bactericidal Assay (rSBA).
Secondary outcome measures
Safety:
1. The percentage of subjects with local and systemic post-immunisation reactions during the first four days, adverse events and Serious Adverse Events (SAEs), as measured at 4 and 28 days after vaccination (reactogenicity and short-term safety)
2. The percentage of subjects with SAEs during the entire study duration, as measured at 182 days (6 months) and 364 days (1 year) (long-term safety)
Immunogenicity:
1. The percentage of subjects with anti-MenPsA titre greater than or equal to 1:8 (defined as seroprotection to MenA) at 28 days after a single vaccine dose, as measured by rSBA assay. The percentage of subjects with anti-MenPsA titer greater than or equal to 1:128 (defined as long-term seroprotection to MenA) will be also considered
2. Geometric Mean Titres (GMTs) for anti-MenPsA antibodies at 28 days after a single vaccine dose, as measured by rSBA assay
3. Evaluation of reverse cumulative distribution curves for MenPsA antibody titres at 28 days after a single vaccine dose, as measured by rSBA assay
4. The percentage of subjects who show a seroconversion for anti-MenPsA total Immunoglobulin G (IgG), i.e. a two-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration, at 28 days after a single vaccine dose, as measured by Enzyme-Linked Immunosorbent Assay (ELISA). The percentage of subjects with a four-fold increase in post-immunisation serum concentration with respect to pre-immunisation serum concentration will be also considered
Overall trial start date
20/08/2007
Overall trial end date
20/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
A subject will be eligible for inclusion if ALL of the following apply at the time of enrolment:
1. Age 2 to 29 years of age (both included)
2. Written informed consent obtained from the subject (for subjects equal to 18 years of age)/parents or legal guardian (for subjects less than 18 years of age)
3. Written informed assent from the subject if and as appropriate within the participating community (e.g., for subjects equal to 13 years of age in the Malian site, for subjects equal to 15 years of age in the Senegal site or for subjects equal to 12 years of age in the Gambia site)
4. Free of obvious health problems as established by medical history including physical examination and clinical judgement of the investigator
5. Subject/parents, or legal guardian capable and willing to come/bring their child or to receive home visits for all follow-up visits
6. Residence in the study area
7. Fully vaccinated according to the local Expanded Program on Immunisation (EPI) schedule (for subjects 2 to 3 years of age only)
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
900
Participant exclusion criteria
Subjects with any of the following criteria at study entry will not be eligible for participation:
1. Previous vaccination against Neisseria meningitidis during the six previous years
2. Known exposure to Neisseria meningitidis during the three previous months
3. History of allergic disease or known hypersensitivity to any component of the two study vaccines and/or following administration of vaccines included in the local program of immunisation
4. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first 28 days after the study vaccination
5. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines
6. Administration of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines or planned administration during the study period
7. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to the administration of study vaccines (Including systemic corticosteroids, this means prednisone, or equivalent, greater than 0.5 mg/kg/day; topical steroids including inhaled steroids are allowed)
8. A family history of congenital or hereditary immunodeficiency
9. History of meningitis or seizures or any neurological disorder
10. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgement)
11. Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion
12. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory tests, which in the opinion of the investigator, might interfere with the study objectives
13. Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study
14. Non residence in the study area or intent to move out within one year
15. Pregnancy or lactation (a negative pregnancy test will be required before vaccination for all women of childbearing potential)
16. Previous inclusion of five family members in the study (i.e., subjects belonging to the same family - biological father, mother, child, and brothers and sisters may be included up to a maximum of five members from the same family)
Recruitment start date
20/08/2007
Recruitment end date
20/09/2008
Locations
Countries of recruitment
Gambia, Mali, Senegal
Trial participating centre
Initiative for Vaccine Research
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
Serum Institute of India Limited (SIIL) (India)
Sponsor details
212/2
Hadapsar
Pune
411 028
India
Sponsor type
Industry
Website
Funders
Funder type
Charity
Funder name
Bill and Melinda Gates Foundation (USA)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
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
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21675889
Publication citations
-
Results
Sow SO, Okoko BJ, Diallo A, Viviani S, Borrow R, Carlone G, Tapia M, Akinsola AK, Arduin P, Findlow H, Elie C, Haidara FC, Adegbola RA, Diop D, Parulekar V, Chaumont J, Martellet L, Diallo F, Idoko OT, Tang Y, Plikaytis BD, Kulkarni PS, Marchetti E, LaForce FM, Preziosi MP, Immunogenicity and safety of a meningococcal A conjugate vaccine in Africans., N. Engl. J. Med., 2011, 364, 24, 2293-2304, doi: 10.1056/NEJMoa1003812.