A first-in-man clinical trial to evaluate the safety and immunogenicity of different doses of a malaria Vaccine (JAIVAC-1) in healthy Indian Male Subjects between 18 to 45 years of age

Phase 1

Completed

• Registration Number: CTRI/2010/091/000301
• Lead Sponsor: International Center for Genetic Engineering and Biotechnology MVDP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

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

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 � 10E6/µL TLC 4.0 to 11.0 � 10E3/µL, platelet count 150

to 500 � 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified