A Vaccine for preventing Pregnancy

Phase I â??II Clinical Trial on Safety, Immunogenicity and probing efficacy of the Revived Recombinant Vaccine against Human Chorionic Gonadotropin (hCG) - R-Î²hCG

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009934

Enrollment

120

Registered

2017-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Recombinant hCGÎ²-LTB Vaccine: The recombinant vaccine is hCGÎ²-LTB prepared as DNA and protein. Primary immunization requires 3 injections (2 DNA and 1 protein injection). The first bo

Eligibility

Inclusion criteria

Inclusion criteria: 1.Willing to participate in the trial and sign the consent form and audio visual recording. 2.Healthy married sexually active women (age group 22-35) who have completed their family with minimum two living children. 3.Has ovulatory cycles 4. Menstruating regularly 5.Not using any hormonal contraceptive since the last 6 months 6.Using non-hormonal IUDs or willing to use non-hormonal IUDs or who have already undergone sterilization. 7.Women after six months of delivery with regular menstrual cycles or six weeks after Medical Termination of Pregnancy (MTP) with return of regular menstrual cycle. 8.Resident of Delhi/NCR

Exclusion criteria

Exclusion criteria: 1.Women who are pregnant or suspecting pregnancy 2.who are currently breast feeding 3.women having â?? i)STD, Reproductive Tract Infection (RTI) and HIV, HCV, Hepatitis B, VDRL, HBsAg infection, ii)Gynaecological disorders iii)history of recurrent abortion iv)history of Joint pains v)secondary infertility vi)any type of suspected cancer vii)allergic to any drug or food, auto-immune and endocrine disorders viii)known systematic disease and on chronic drug therapy i.e. hormone therapy ix)any psychiatric disorders x)BMI above 30, (obese) xi)PCOS (using Rotterdam Criteria) xii) any problem with IUDs 4.who are currently using any other hormonal contraceptive

Design outcomes

Primary

Measure	Time frame
To determine the safety and immunogenicity of hCGÎ²-LTB Vaccine in sexually active healthy women and prove its ability to prevent pregnancy in sexually active women without impairment of ovulation and derangement of menstrual regularity and bleeding profiles.Timepoint: approximately after 6 months of primary immunization	—

Secondary

Measure	Time frame
Any adverse eventTimepoint: during and after the immunization	—

Countries

India

Contacts

Public ContactDr R S Sharma

Indian council of Medical Research

head.rbmh@gmail.com9891052057

Outcome results