Safety and immunogenicity study of mRNA based vaccine (HGCO19) against COVID-19 in healthy adult participants.

Phase 1

Completed

Conditions: Active immunization for prevention of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

Registration Number: CTRI/2021/04/032688

Lead Sponsor: Gennova Biopharmaceuticals Limited

Brief Summary: This is a dose ranging, placebo-controlled, Phase I study in healthy adult subjects. The study will evaluate escalating dose strengths of HGCO19 administered intramuscularly as a two-dose regimen 28 days apart. Phase-1 study is a randomized, open-label, placebo-controlled, multi-centre study to assess the safety and immunogenicity of HGCO19 vaccine. Phase-1 study will enrol at least 72 healthy participants in the age group of 18-70 years.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 72

Inclusion Criteria

Male and female subjects aged between 18 to 70 years(both inclusive) at randomization.
Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator.
Subject should be capable and willing to give voluntary written informed consent prior to inclusion in the study.
Able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
Negative / Non-reactive for antibodies against SARS-CoV-2.
Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2 within 72 hours prior vaccination.
Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child bearing potential should be willing to follow effective birth control methods for duration of the study.
Note: Birth control methods include vasectomised subject/partner; or any 2 of the following methods: intrauterine device; oral, transdermal, injected, or implanted contraceptive; condoms; occlusive cap (diaphragm or cervical vault caps); spermicidal foam/gel/cream, etc.
OR Exception to the above are male subjects who are infertile (post vasectomy with documented azoospermia or bilateral orchidectomy) and female subjects who are of non-childbearing potential [who are surgically sterile (hysterectomy, bilateral tubal ligation or bilateral salpingo-oophorectomy) or postmenopausal subjects with amenorrhea for at least 2 years].

Exclusion Criteria

Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection.
Subjects with a BMI > 30 kg/m2 3.
Protocol defined laboratory assessments outside the range/limit defined in Appendix 2.
Any other laboratory value if â‰¥ Grade 2 as per DAIDs criteria.
Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health 4.
Any illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.
Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g. healthcare worker in direct care of COVID-19 patients, front line workers in COVID 19 hotspots / outbreak areas).
History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.
Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature â‰¥38Â°C or â‰¥100.4 Â°F) within 48 hours prior to vaccination.
History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease.
Subject has uncontrolled chronic disease including asthma, diabetes (HbA1c of >9%), hypertension (Systolic Blood pressure of >160 mm of Hg and/ or Diastolic Blood Pressure of >100 mm of Hg), thyroid disorder as assessed by the Investigator.
Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study.
Prior major surgery or any radiation therapy within 4 weeks of Screening visit.
Positive serologic test for HIV 1 and 2, HBsAg or HCV.
Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).
Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.
Eczema or other significant skin lesion or infection at the site of vaccination.
Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit.
Bleeding diathesis or condition associated with prolonged bleeding.
Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate.
Any other condition which in the opinion of the Investigator may affect subjectâ€™s safety or participation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3. Occurrence, severity and relationship of unsolicited AEs up to 28 days following each dose of vaccination.	Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.
4. Occurrence of SAE at any time during study participation.	Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.
5. Changes in safety assessments including laboratory parameters and vital signs from baseline.	Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.
1. Occurrence and severity of local reactogenicity AEs for 7 days following each dose of vaccination.	Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.
2. Occurrence, severity and relationship of systemic reactogenicity AEs for 7 days following each dose of vaccination.	Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.

Secondary Outcome Measures

Name	Time	Method
Exploratory Outcome:	7. Number of subjects with laboratory confirmed COVID-19 infection during study participation.
1. Geometric mean titer (GMT) as measured by IgG-ELISA to SARS-CoV-2 Spike protein and against the RBD of Spike protein at Day 57 (28 days post Dose 2).	2. Geometric mean fold rise (GMFR) in SARS CoV-2 Spike protein-specific binding antibody (IgG) levels and in RBD of Spike protein IgG levels from baseline at Day 57.
Exploratory Outcomes:	3. Relationship (correlation analysis) between SARS-CoV-2 neutralizing antibody and S-protein and RBD of S-protein IgG titers at Days 29, 57, 119, and 209.

Trial Locations

Locations (4): Dr. D.Y. Patil Medical College Hospital and Research Center
🇮🇳
Pune, MAHARASHTRA, India
Guru Nanak Hospital
🇮🇳
Faridabad, HARYANA, India
KEM Hospital Research Center
🇮🇳
Pune, MAHARASHTRA, India
Rajashree Chhatrapati Shahu Maharaj Govt. Medical College
🇮🇳
Kolhapur, MAHARASHTRA, India
Dr. D.Y. Patil Medical College Hospital and Research Center
🇮🇳Pune, MAHARASHTRA, India
Dr Prakash Shende
Principal investigator
09822246881
drprakashshende1979@gmail.com