| CTRI Number |
CTRI/2010/091/000301 [Registered on: 27/04/2010] |
| Last Modified On: |
15/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
A Phase I, Randomised, Controlled, Dose-Escalating, Single-Blind Clinical Trial to Evaluate the Safety and Immunogenicity of JAIVAC-1 Vaccine (PfMSP-119 and PfF2) formulated with Montanide ISA 720 in Healthy Indian Male Subjects between 18 to 45 Years of Age |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JAIVAC-1_1_09 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Preethi Shivyogi |
| Designation |
|
| Affiliation |
|
| Address |
Lotus Labs Pvt. Ltd.
100 ft. road, 3rd Block Koramangalam
Bangalore
KARNATAKA
560034
India |
| Phone |
91-80-22370912 |
| Fax |
91-80-22370911 |
| Email |
preethishivyogi@lotuslabs.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Manali Rane |
| Designation |
|
| Affiliation |
|
| Address |
DiagnoSearch Life Sciences Pvt. Ltd.
Dosti Pinnacle,
Plot No. E-7, Road No. 22,
Wagle Industrial Estate,
Thane
MAHARASHTRA
400 604
India |
| Phone |
022-67776300 |
| Fax |
022-66754090 |
| Email |
manali.rane@diagnosearch.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Chetan ChitnisProf Virendra Chauhan |
| Designation |
|
| Affiliation |
|
| Address |
1)Malaria Vaccine Development Program (MVDP)
2)International Center for Genetic Engineering and Biotechnology(ICGEB)
1)The Capital Court,Transcend Business Centre
Olof Palme Marg
2)Aruna Asaf Ali Road
New Delhi
DELHI
110067
India |
| Phone |
011-26742895 |
| Fax |
011-26742316 |
| Email |
cchitnis@gmail.com |
|
|
Source of Monetary or Material Support
|
| European Vaccine Initiative
UniversitätsKlinikum Heidelberg
Im Neuenheimer Feld ? 307
69120 Heidelberg - Germany
|
|
Primary Sponsor
Modification(s)
|
| Name |
International Center for Genetic Engineering and Biotechnology MVDP |
| Address |
Aruna Asaf Ali Road, New Delhi-110067,India
The Capital Court,Transcend Business Centre
Olof Palme Marg, New Delhi-110067
India
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| European Vaccine Initiative
UniversitätsKlinikum Heidelberg
Im Neuenheimer Feld ? 307
69120 Heidelberg - Germany
|
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr James John |
Lotus Lab Pvt. Ltd |
100 feet road,3rd Block, Koramangala-560034
Bangalore
KARNATAKA |
91-80-22370912
91-80-22370911
james@lotuslabs.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Consultants |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Testing Plasmodium falciparum Malaria Vaccine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hepatitis B vaccine |
Details provided in "Brief Summary" |
| Intervention |
JAIVAC-1 Vaccine (PfMSP-119 and PfF2) formulated with Montanide ISA 720 |
Deatils provided in "Brief Summary" |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
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) |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
NA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ? 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.
|
NA |
|
Target Sample Size
Modification(s)
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
09/08/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This Phase I, first in man study is designed as a randomized, controlled, single-blind and dose-escalating clinical study for the assessment of the safety and immunogenicity of JAIVAC-1 malaria vaccine (PfMSP-119 and PfF2) formulated with Montanide ISA 720 as an adjuvant in healthy Indian male subjects between 18 to 45 years of age.
The study involves testing of three (3) different dosages of JAIVAC-1 malaria vaccine in three different dosage cohorts. Hepatitis B vaccine will serve as an active control.
Each Cohort will have 15 subjects. The randomization schedule will be 2:1, i.e. 10 subjects will receive the investigational vaccine and 5 subjects will be administered hepatitis- B, the control vaccine. Thus, in total in this study, 30 subjects will receive JAIVAC-1―Montanide ISA720 (10 subjects at each dosage cohort) and 15 subjects will receive control vaccine.
Both the study vaccines will be administered via intramuscular route and shall have a 3-dose schedule on Days 0, 28 and 180.
In the first Cohort subjects will receive 0.1 ml of investigational vaccine. If found to be safe and well tolerated second cohort will receive 0.25 ml of investigational vaccine and finally Cohort 3 will receive 0.5 ml of investigational vaccine. Each cohort will be staggered into sub-cohorts such that the subjects in each cohort will be enrolled over a three-day period. The first three (3) subjects of the first dose (Cohort 1) will be kept under observation for 24 hrs following vaccination. The decision of the 24-hour housing for the remaining subjects will be jointly taken by the Principal Investigator and Medical and Safety Monitor, DLS.
|