Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201303000434188 Date of Approval: 12/10/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Helmvacc
Official scientific title Effect of antihelminthic treatment on vaccine immunogenicity in a population with a high prevalence of geohelminth infections
Brief summary describing the background and objectives of the trial Infection with geohelminths is a major public health problem affecting 20% of the world population. As access to public health programs is widely lacking, geohelminthiasis is considered by the World Health Organisation (WHO) as one of the 13 most neglected tropical diseases with serious health, nutritional and social outcomes for affected individuals. Furthermore immunity changes upon infection with geohelminths. Immunisation programs for infants are well implemented in areas where geohelminth infections are common and this infrastructure is the basis for the testing and future implementation of new vaccines for poverty related diseases such as malaria. Little is known about the interaction of geohelminth infections and immune responses against vaccine antigens. Pilot studies from Gabon have shown that presence of geohelminths significantly reduce immune responses against an experimental vaccine candidate. Therefore in this study we selected three vaccines of different classes to assess immunogenicity in school children pre-treated with antihelminthic treatment or placebo before each vaccination to discover the effect of pre-treatment on immune responses to vaccine antigens. These investigations are important because they may change the vaccination policy in a population with a high prevalence of geohelminth infection.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Helminth infection,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/12/2011
Actual trial start date 30/11/2012
Anticipated date of last follow up 31/12/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 312
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Randomisation was computer generated. Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Albendazole 400mg single dose single treatment Antihelminthic treatment 156
Control Group Placebo control single dose single dose 156 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Aged from 6 to 10 years (primary schoolchildren) who give assent to participate. ¿Written (signed or in case of illiteracy witnessed by an impartial witness) informed consent obtained from parent(s) or guardian(s) of the child. ¿Good general health upon clinical examination ¿Resident in the area until the end of the study ¿Participation in another clinical trial. ¿Contraindication to antihelminthic treatment or to the administration of one of the chosen vaccines including i.m. or s.c. administration ¿Known immunization against the vaccine Ags. ¿Known infection with the pathogen of one of the vaccine Ags in the past except influenza because the influenza vaccine contains the actual strains recommended by the WHO each year. ¿Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g.,malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). However subjects who have received less than 15 days of immunosuppressants or other immune modifying drugs should not be contraindicated from receiving subsequent vaccinations. Also, for corticosteroids, prednisone <20 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed. ¿Acute disease at the beginning of the study and before vaccination, determined by physical examinations at these time points. ¿Known chronic disease and chronic infection*1. If a child is only febrile at the time of the vaccination the child will be vaccinated when infection is cured ¿Signs of symptoms of geohelminth infection 6 Year(s) 10 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Regional Independent Ethics committee Lambaréné CERIL
Ethics Committee Address
Street address City Postal code Country
Mrs. Chris B.P. 250 Lambaréné, Gabon Lambaréné Gabon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Comité dÈthique Regional Indépendant de Lambaréné (CERIL)
Ethics Committee Address
Street address City Postal code Country
Lambaréné BP250 Gabon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome antibody titer to vaccine antigens d0; d28 and d84 post vaccination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Albert Schweitzer Hospital and Centre de Recherche Médicale de Lambaréné (CERMEL) Lambaréné 118 Gabon
FUNDING SOURCES
Name of source Street address City Postal code Country
Bundesminsiterium für Bildung und Forschung Heinrich-Konen-Str. 1 Bonn 53227 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Ayola Akim Adegnika, MD, PhD Albert Schweitzer Hospital and Centre de recherche Médicale de Lambaréné (CERMEL) Lambaréné BP 118 Gabon Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr. Meral Esen Wilhelmstr. 27 Tübingen 72074 Germany
Dr. Selidji Agnandji Albert Schweitzer Hospital and Centre de Recherche Médicale de Lambaréné (CERMEL) Lambaréné 118 Gabon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Meral Esen meral.esen@uni-tuebingen.de 004970712980240 Wilhelmstr. 27
City Postal code Country Position/Affiliation
Tübingen 72074 Germany Institut für Tropenmedizin
Role Name Email Phone Street address
Public Enquiries Meral Esen meral.esen@uni-tuebingen.de 004970712980240 Wilhelmstr. 27
City Postal code Country Position/Affiliation
Tübingen 72074 Germany Group leader/ Institut für Tropenmedizin
Role Name Email Phone Street address
Scientific Enquiries Selidji Agnadji agnandjis@lambarene.org 0024107353114 Albert Schweitzer Hospital and Centre de Recherche Médicale de Lambaréné (CERMEL)
City Postal code Country Position/Affiliation
Lambaréné Gabon Co-PI
REPORTING
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