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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02647489 |
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Date of registration:
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04/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Immunogenicity of the Placental Malaria Vaccine Candidate PAMVAC Variously Adjuvanted
PAMVAC |
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Scientific title:
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Safety and Immunogenicity of the Placental Malaria Vaccine Candidate PAMVAC Adjuvanted With Alhydrogel, GLA-SE or GLA-LSQ in Healthy Malaria-Naïve Adults and Healthy, Lifelong Malaria-Exposed, Nulligravid Adult Women |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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66 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02647489 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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Benin
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Contacts
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Name:
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Benjamin G Mordmüller, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Tübingen |
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Name:
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Saadou Issifou, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Université d'Abomey-Calavi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy male and female volunteers aged 18-45 years.
- Able and willing (in the investigator's opinion) to comply with all trial
requirements.
- General good health based on history and clinical examination
- Written informed consent
- Women only: Must agree to practice continuous effective contraception for the duration
of the trial (a method which results in a low failure rate; i.e. less than 1% per
year). Women will be counseled about effective contraception methods and, if required,
can be provided with adequate contraceptives by the investigator team.
- Available to participate in follow up for the duration of trial (36 weeks following
first injection)
- Reachable by phone during the whole trial period
Exclusion Criteria:
- Pregnancy, lactation or intention to become pregnant during the trial
- Previous participation in a malaria vaccine trial
- HIV infection
- Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia,
recurrent, severe infections and chronic (more than 14 days) immunosuppressant
medication within the past 6 months (inhaled and topical steroids are allowed)
- Presence of autoimmune diseases requiring systemic treatment (e.g. rheumatic diseases)
- Use of immunoglobulins or blood products within 3 months prior to enrolment
- Receipt of an investigational product in the 30 days preceding enrolment, or planned
receipt during the trial period
- History of malaria or travel in malaria-endemic areas within the past 6 months
- Intention to travel to malaria endemic countries during the trial period
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in
situ)
- History of serious psychiatric condition that may affect participation in the trial
- Any other serious chronic illness requiring hospital specialist supervision
- Suspected or known current alcohol abuse as defined by an alcohol intake of greater
than 60 g (men) or 40 g (women) per day or a carbohydrate deficient transferrin (CDT)
level =2.5%
- Suspected or known injecting drug abuse in the 5 years preceding enrolment
- Positive for hepatitis B surface antigen (HBs-antigen)
- Seropositive for hepatitis C virus (antibodies to HCV)
- Volunteers unable to be closely followed for social, geographic or psychological
reasons
- Known hypersensitivity to any of the vaccine components (adjuvant or peptide)
- Any clinically significant abnormal finding on biochemistry or hematology blood tests,
urine analysis or clinical examination
- History of seizure, except for sporadic febrile convulsions in childhood
- Any other significant disease, disorder or finding which, in the opinion of the
investigator, may significantly increase the risk to the volunteer because of
participation in the trial; affect the ability of the volunteer to participate in the
trial or impair interpretation of the trial data.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria, Antepartum
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Intervention(s)
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Biological: GLA-SE
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Biological: GLA-LSQ
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Other: Placebo
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Biological: Alhydrogel
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Biological: PAMVAC
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Primary Outcome(s)
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Number and grade of adverse events (Grade 1-3 and serious adverse events) possibly, likely and definitely related to vaccination
[Time Frame: From the first administration of the interventions through study completion, an average of 1 and a half years]
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Secondary Outcome(s)
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Area under the curve of anti-PAMVAC IgG concentration
[Time Frame: Before first administration, 1, 4, 5, 8, 9, 12, 24 and 36 weeks after first administration]
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Secondary ID(s)
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PAMVAC1_15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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