Phase 1 Clinical study to test the safety of Plasmodium Vivax (Malaria) Vaccine in Healthy Volunteers.
- Registration Number
- CTRI/2016/09/007289
- Lead Sponsor
- International Centre for Genetic Engineering and Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1.A Male between the ages of 18 to 45 years (both inclusive) (age at informed consent).
2.Willing and having the capacity to provide voluntary free informed consent for participation evidenced by signing of the IRB/IEC approved informed consent
3. Subject is in good general health and is free from clinically significant health problems as determined by medical history, physical examination and clinical laboratory evaluation.
4. Willing to be available for the duration of the study, contactable by phone.
5. Capable and willing to complete and return subject diary cards, and to attend all follow-up visits, including unscheduled visits.
6. Willing to undergo HIV test
7. Must agree to use one of the following medically-acceptable birth control measures throughout the duration of the study (birth control counselling and measures will be provided by clinical trial site as required)
Double barrier method (e.g. condom with spermicidal jelly) OR
Subjects must be surgically sterile (undergone vasectomy)
8. Willing to take Intramuscular injection.
1. Any past history of malaria
2. Simultaneous participation in any other intervention clinical trial at the CRO
3. Subject with evidence of previous exposure to vivax malaria parasite as determined by presence of IgG antibodies against PvDBPIl (ELISA).
4. Has prior history of immunisation with Hepatitis B vaccine.
5. History of receipt of any other candidate malaria vaccine.
6. History of allergic reactions,hypersensitivity or anaphylaxis to immunizations, to any of the components of the study vaccines (including adjuvant or peptide) or of serious allergic reactions that required hospitalisation or emergency medical care.
7. Use of an investigational or non-registered drug or vaccine within thirty (30) days prior to enrolment or expects to receive such an agent during the study period.
8. Administration of any vaccination or gamma globulin during the three-month period prior to the first Immunization or planned use during the study.
9. Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs or cytotoxic therapies(chemotherapy or radiotherapy) within six months prior to the first Immunization. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids.
10. Received a blood transfusion within the past 3 months
11. Evidence of any acute or chronic illness (including cardiovascular, pulmonary,
neurological, hepatic, rheumatic,haematological, immunological, metabolic, or renal disorders), as determined by history or clinical examination or laboratory screening.
12. History of splenectomy
13. Has a history of autoimmune disease (including inflammatory bowel disease,haemolytic anaemia, autoimmune hepatitis, rheumatoid arthritis, lupus, etc.) or connective tissue disease.
14. Subject has clinically Significant laboratory abnormalities, which will include haematology, biochemistry, urinalysis, at the time of screening as determined by the Investigator.
15. Clinical or laboratory presence of Hepatitis B, C or HIV infection or Syphilis.
16. Subject with an abnormal 12-lead ECG at screening associated with relevant clinical symptoms/signs suggestive of cardiac pathology (including conduction disturbances).
17. Subject with an abnormal Chest X-Ray associated with relevant clinical
symptoms/signs of respiratory pathology at screening/ anytime in the past 6
months.
18. Subject gives a history of social, occupational and/ or family problems due to
illicit alcohol or drug abuse (to be determined by Urine Drug Screen) within the past 12 months.
19. Has any other condition that, in the opinion of the Principal Investigator, may jeopardise the safety and rights of the volunteer, may interfere with the capacity to provide free and willing informed consent or render the subject unable to comply with the requirements of the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the safety and reactogenicity of three different doses of malaria vaccine candidate. <br/ ><br>Timepoint: Immediate reactogenicity: within 1st hrs after each Immunization, <br/ ><br>â?¢ Local and systemic Solicited AE(s): From 1hrs post Immunization till day 7 after each immunization <br/ ><br>â?¢ Local and systemic Unsolicited AE(s):From 1hrs post Immunization till Day 26 days after each Immunization <br/ ><br>â?¢SAE:From the signing of ICD till the last follow-up visil. <br/ ><br>â?¢ Lab Safety: AEs related to clinical laboratory investigations (bood and urine)monitored at day 7 after each immunisation and at the end of the visit.
- Secondary Outcome Measures
Name Time Method â?¢ Humoral immune response against PvDBPIl by IgG ELISA <br/ ><br>â?¢ Test recognition of native antigen in late stage P.vivax schizonts by <br/ ><br>Immunofluorescence assay (IFA). <br/ ><br>â?¢ ability of Anti-PvDBPIi antibodies to block the interaction between <br/ ><br>PvDBPil and Duffy antigen receptor chemokine (DARC) by ELISA based Binding Inhibition Assay (BIA) <br/ ><br>â?¢ Subclasses of IgG (lgG1, IgG2, IgG3, IgG4) by ELISATimepoint: Thrice during the trial period (Day 0, Day 84 and Day 180 of participation)