Janssen COVID-19 Vaccine
- Generic Name
- Janssen COVID-19 Vaccine
- Drug Type
- Biotech
- Unique Ingredient Identifier
- JT2NS6183B
- Background
The Janssen COVID-19 vaccine (Ad26.COV2.S) is a recombinant vaccine that contains an adenovirus serotype 26 (Ad26) vector expressing a stabilized SARS-CoV-2 spike protein. The vaccine was created in collaboration with Johnson and Johnson (J&J), Janssen Pharmaceutical, and the Beth Israel Deaconess Medical Center. A preclinical study in hamsters infected with SARS-COV-2 infection showed a single immunization with the vaccine-elicited neutralizing responses and protected against SARS-CoV-2 induced pneumonia and mortality, providing protection against the disease progression. Follow-up preclinical studies in rhesus monkeys showed that the Ad26 vaccine produced a robust response and provided near perfect protection in nasal swabs and bronchoalveolar lavage following SARS-COV-2 challenge. As of June 2020, a Phase 1/2 clinical trial in adult humans was announced to evaluate the safety, immunogenicity, and efficacy of the ad26.COV.S vaccine in 1045 healthy adults between the ages of 18-55 (NCT04436276). The Janssen COVID-19 vaccine is available under an Emergency Use Authorization (EUA) in the US.
- Indication
Janssen COVID-19 Vaccine is indicated for active immunization for the prevention of coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 virus in individuals 18 years of age and older.
In the US, Janssen COVID-19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
- Associated Conditions
- Coronavirus Disease 2019 (COVID‑19)
- Associated Therapies
- Active Immunization
Safety, Tolerability and Immunogenicity of Alveavax-v1.2, a BA.2/Omicron-optimized, DNA Vaccine for COVID-19 Prevention
- Conditions
- Sars-CoV-2 Infection
- Interventions
- First Posted Date
- 2023-05-06
- Last Posted Date
- 2023-05-06
- Lead Sponsor
- Alvea Holdings, LLC
- Target Recruit Count
- 130
- Registration Number
- NCT05844202
- Locations
- 🇿🇦
JOSHA Research, Bloemfontein, Free State, South Africa
🇿🇦MERC Research Pty Ltd, Middelburg, Mpumalanga, South Africa
🇿🇦NMMM Pharmmedica Health and Clinical Research, Johannesburg, Gauteng, South Africa
Phase 2a Trial to Evaluate Safety and Immunogenicity of COVID-19 Vaccine Strategies in HIV-infected/Uninfected Adults.
- Conditions
- COVID-19
- Interventions
- First Posted Date
- 2022-08-25
- Last Posted Date
- 2024-07-15
- Lead Sponsor
- The Aurum Institute NPC
- Target Recruit Count
- 694
- Registration Number
- NCT05515042
- Locations
- 🇿🇦
The Aurum Institute: Pretoria Clinical Research Centre, Pretoria, Gauteng, South Africa
🇿🇦The Aurum Institute: Gavin J Churchyard Legacy Centre, Klerksdorp, North West Province, South Africa
🇿🇦The Aurum Institute: Rustenburg Clinical Research Centre, Rustenburg, North-West Province, South Africa
Homologous vs Heterologous Third Vaccination in Kidney Transplant Recipients Kidney Transplant Recipients
- Conditions
- COVID-19
- Interventions
- First Posted Date
- 2022-04-12
- Last Posted Date
- 2022-04-20
- Lead Sponsor
- Medical University of Vienna
- Target Recruit Count
- 200
- Registration Number
- NCT05324319
- Locations
- 🇦🇹
Medicial University of Vienna, Vienna, Austria
A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults
- Conditions
- COVID-19 Prevention
- Interventions
- First Posted Date
- 2021-10-25
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.
- Target Recruit Count
- 861
- Registration Number
- NCT05091307
- Locations
- 🇺🇸
Wr McCr Llc, San Diego, California, United States
🇵🇱Synexus Polska Sp z o o Oddzial w Katowicach, Katowice, Poland
🇵🇱Synexus Polska Sp Z O O Oddzial W Lodzi, Lodz, Poland
A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine in Brazil
- Conditions
- Covid19
- Interventions
- Drug: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineDrug: ChAdOx1 nCoV-19 Covid-19 Vaccine
- First Posted Date
- 2021-09-22
- Last Posted Date
- 2023-11-07
- Lead Sponsor
- Hospital Moinhos de Vento
- Target Recruit Count
- 4574
- Registration Number
- NCT05052307
- Locations
- 🇧🇷
Unidade Básica de Saúde Jardim Cosmos, Toledo, PR, Brazil
🇧🇷Unidade de Pronto Atendimento Pediátrico Dr. José Ivo Alves da Rocha, Toledo, PR, Brazil
🇧🇷Pronto Atendimento Municipal de Toledo, Toledo, Paraná, Brazil
A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive
- Conditions
- Coronavirus Disease-2019 (COVID-19) Prevention
- Interventions
- First Posted Date
- 2021-08-16
- Last Posted Date
- 2025-02-04
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.
- Target Recruit Count
- 304
- Registration Number
- NCT05007080
- Locations
- 🇧🇷
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP, Ribeirão Preto, Brazil
🇿🇦Setshaba Research Centre, Soshanguve, South Africa
🇦🇷CIPREC, Buenos Aires, Argentina
A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
- First Posted Date
- 2021-08-10
- Last Posted Date
- 2025-02-04
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.
- Target Recruit Count
- 1541
- Registration Number
- NCT04999111
- Locations
- 🇺🇸
Central Phoenix Medical Clinic, Phoenix, Arizona, United States
🇺🇸Synexus Clinical Research US Inc, The Villages, Florida, United States
🇺🇸Anaheim Clinical Trials, LLC, Anaheim, California, United States
A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults
- First Posted Date
- 2021-06-01
- Last Posted Date
- 2025-02-04
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.
- Target Recruit Count
- 1609
- Registration Number
- NCT04908722
- Locations
- 🇿🇦
Synexus Helderberg Clinical Research Centre, Cape Town, South Africa
🇿🇦Ndlovu Elandsdoorn Site, Dennilton, South Africa
🇿🇦Stanza Clinical Research Centre : Mamelodi, Mamelodi East, South Africa
Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines
- Conditions
- COVID-19
- Interventions
- First Posted Date
- 2021-05-17
- Last Posted Date
- 2025-04-20
- Target Recruit Count
- 867
- Registration Number
- NCT04889209
- Locations
- 🇺🇸
University of Rochester Medical Center - Vaccine Research Unit, Rochester, New York, United States
🇺🇸Cincinnati Children's Hospital Medical Center Vaccine Research Center, Cincinnati, Ohio, United States
🇺🇸University of Pittsburgh - Medicine - Infectious Diseases, Pittsburgh, Pennsylvania, United States
A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19)
- First Posted Date
- 2021-02-21
- Last Posted Date
- 2025-04-29
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.
- Target Recruit Count
- 51
- Registration Number
- NCT04765384
- Locations
- 🇧🇷
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base, Sao Jose do Rio Preto, Brazil
🇺🇸Medpharmics, LLC, Albuquerque, New Mexico, United States
🇺🇸Maximos OB/GYN, League City, Texas, United States
Drug Development Updates
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