None listed
Conditions
Interventions
Intervention1: JAIVAC-1 Vaccine (PfMSP-119 and PfF2) formulated with Montanide ISA 720: Deatils provided in "
Brief Summary"
Control Intervention1: Hepatitis B vaccine: Details provided in "
Sponsors
International Center for Genetic Engineering and Biotechnology MVDP
European Vaccine Initiative
Universitä
tsKlinikum Heidelberg
Im Neuenheimer Feld ? 307
69120 Heidelberg - Germany
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male subject aged 18 to 45 years (both inclusive) 2. Subject with general good health based on the medical history and clinical examination 3. Subject must be willing to sign the Informed Consent Form 4. Subject must be reachable by phone during the entire study period (12 months) 5. Subject must be capable and willing to complete and return diary cards and to attend all follow-up visits 6. Male subject must agree to use one of the following medicallyacceptable birth control measures throughout the duration of the study (birth control counselling and measures will be provided by sites as required) ? Double barrier method (e.g. condom with spermicidal jelly) used for the entire study period Or ? Should be Surgically sterile (vasectomy)
Exclusion criteria
Exclusion criteria: 1. Subject with evidence of IgG antibodies against PfMSP-119 and PfF2 as measured by ELISA 2. Subject with prior history of immunisation with Hepatitis B vaccine 3. Subject with known history of malaria 4. Subject with history of allergic reactions, hypersensitivity or anaphylaxis to any of the components of the study vaccines (JAIVAC-1 ? Montanide ISA 720 malaria vaccine or Hepatitis B vaccine) (including adjuvant or peptide) or with history of serious allergic reactions to any substance, requiring hospitalisation or emergency medical care 5. Subject with previous vaccination with any other malaria candidate vaccines 6. Subject with use of an investigational or non-registered drug or vaccine other than the study vaccines within three (3) months preceding the first study vaccination, or planned use during the entire clinical trial period 7. Subject, who receives any vaccination or gamma globulin during the three-month period prior to the first vaccination 8. Subject with chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccination. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids 9. Subjects will be excluded if AST 40 IU/L, ALT 41 IU/L, γ GT 71 IU/L, Total Bilirubin 1.2 mg/ dL, Indirect Bilirubin 1.2 mg/ dL, Direct Bilirubin 0.4 mg/dL, Serum Creatinine 1.2 mg/ dL(Appendix B and B-1). 10. Subjects will be excluded in case of out of range values for the following parameters: Hemoglobin 13 to 18 g/ dL, RBC count 4.0 to 7.0 Ã? 10E6/µL TLC 4.0 to 11.0 Ã? 10E3/µL, platelet count 150 to 500 Ã? 10E3/µL, Neutrophils 40 to 75 % or Eosinophils 10 %, Sodium 136 to 145 mEq/L, Potassium 3.5 to 5.1 mEq/L, Random Blood Glucose 45 to 130 mg/dl and Alkaline Phosphatase 40 to 129 U/L (Appendix B and B-1) 11. Subjects with other clinically significant abnormal laboratory values based on the normal reference range (Refer Appendix B and B1) apart from the laboratory parameters listed above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety profile will be assessed on the basis of the following criteria �� Immediate reactogenicity (any event occurring within the first three (3) hours after each vaccination, with emphasis on allergic reactions) �� Local and systemic reactogenicity (any event occurring from three (3) hours post vaccination on Day 0 till Day 14 after each dose) �� Any unsolicited adverse events 28 days after each vaccination �� Any Serious Adverse Event (SAE) occurring from the first dose of vaccine till the last follow-up visit. �� Biological safety, 28 days after each vaccination, in reference with the baseline before the first dose, by measuring the following parameters: ? Haematology: RBC Count, Haemoglobin*, Haematocrit/Packed Cell Volume (PCV), MCV (Mean Corpuscular Volume), MCH (Mean Corpuscular Haemoglobin), MCHC (Mean Corpuscular Haemoglobin Concentration) on Days -14, 28, 56, 180, 208, 365 ? Platelet Count and Total Leukocyte Count (TLC) along with Differential Leukocyte Count (DLC) on Days -14, 28, 56, 180, 208, 365. *If the haemoglobin drops below 13 gm/dL, then a direct Coomb?s test and a peripheral blood smear/film will be prepared and examined for evidence of possible haemolysis ? Serum Chemistry: Potassium, Sodium, AST, ALT, Direct, Indirect and Total Bilirubin, Alkaline Phosphatase, Gamma Glutamyl Transpeptidase (γGT), Creatinine, and Random blood glucose on Days -14, 28, 56, 180, 208, 365 The Investigator will be responsible for causality assessment i.e. assessment of the relationship of the AE to either of the assigned the study vaccines, using the following definitions: related or not related.Timepoint: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| ? The humoral response to the candidate vaccine antigen will be assessed (quantitative assessment) by measuring the level of IgG antibodies developed against PfMSP-119 and PfF2 by ELISA on Days 0, 28, 56, 180, 208 and 365 ? The humoral response to the candidate vaccine antigen will be assessed (qualitative assessment) to verify the ability of the IgG antibodies developed against PfMSP-119 and PfF2 to recognise the native proteins, namely, PfMSP1 and EBA175 in late stage P. falciparum schizonts and merozoites by IFA on Days 0, 28, 56, 180, 208 and 365. Timepoint: NA | — |
Countries
India
Contacts
Public ContactDr Chetan ChitnisProf Virendra Chauhan
Outcome results
None listed