Other substances

rAd26-S

An experimental adenoviral vaccine with the SARS-CoV-2 Spike protein immunogen.

Phase of research

Potential treatment - clinical evidence

How it helps

Vaccine

Drug status

Experimental

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 Supporting references
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 Contradictory references
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 AI-suggested references
3
 Clinical trials

General information

rAd26-S is an experimental vaccine in phase I/II clinical trials (NCT04436471 and NCT04437875). It is based on adenoviral vector carrying the gene for the SARS-CoV-2 spike protein. Preliminary results suggest its safety and immunogenicity in healthy individuals (Logunov et al., 2020).

 

Supporting references

Link Tested on Impact factor Notes Publication date
Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia
Non-randomized non-controlled open trial Viral vector Phase II clinical trial Phase I clinical trial 		Healthy adults 60.39

The experimental vaccine produces strong humoral and cellular immune responses in healthy adults without serious side effects. Sample size: 9 (phase I) + 20 (phase II) (with additional rAd5-S administration). Dosage: IM; in the phase II, rAD26-S administration was followed by rAd5-S on day 21.


 Sep/04/2020

Clinical trials

ID Title Status Phase Start date Completion date
NCT04760730 Safety and Immunogenicity Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime Boost Regimen for the Prevention of Coronavirus Disease 2019 (COVID-19) Recruiting Phase 1|Phase 2 Jul/13/2021 Jun/30/2022
  • Alternative id - CV03872091
  • Interventions - Biological: AZD1222|Biological: rAd26-S
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Tawam Hospital, Al Ain, United Arab Emirates
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Prevention
  • Enrollment - 100
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Antibody seroconversion rate (≥ 4 fold increase from baseline) against SARS-CoV-2 Spike protein 29 days post second vaccination|Incidence of local and systemic solicited Adverse Events (AEs) for 7 days following each vaccination|Incidence of unsolicited AEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) through 29 days post each vaccination|Antibody seroconversion rate (≥ 4 fold increase from baseline) against SARS-CoV-2 Spike protein 29 days post first vaccination|Antibody seroconversion rate (≥ 4 fold increase from baseline) against Receptor Binding Domain (RBD) antigen|Сhange from baseline Geometric Mean Titre (GMT) of immunogenicity against Spike and RBD antigens at Day 15, 29, 57, 180.|Change from baseline Geometric Mean Fold Rise (GMFR) of immunogenicity against Spike and RBD antigens at Day 15, 29, 57, 180.|Antibody seroconversion rate (≥ 4 fold increase from baseline) SARS-CoV-2 neutralising antibodies 29 days post each vaccination (Day 29 and Day 57)|Change from baseline GMT of immunogenicity as measured by SARS-CoV-2 neutralising antibodies at Day 15, 29, 57, 180.|Change from baseline GMFR of immunogenicity as measured by SARS-CoV-2 neutralising antibodies at Day 15, 29, 57, 180.|Change from baseline the number of proliferating CD4 and CD8 cells in response to mitogen stimulation and their ratio in trial subjects.|Change from baseline Interferon gamma concentration in response to S Ag simulation
NCT04686773 Open-label, Non-randomized, Non-comparative, Phase II Study of Safety and Immunogenicity of Combination of AZD1222 and rAd26-S for COVID-19 Prevention Active, not recruiting Phase 2 Mar/05/2021 Mar/07/2022
  • Alternative id - CV03872092
  • Interventions - Biological: AZD1222|Biological: rAd26-S
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Public legal entity "Baku Health Center", Baku, Azerbaijan
  • Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
  • Enrollment - 100
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the second vaccination.|Incidence of local and systemic solicited Adverse Events (AEs) for 7 days post each dose|Incidence of unsolicited AEs, serious adverse events (SAEs) and AEs of special interest|Antibody seroconversion rate to SARS CoV-2 Spike protein 29 days after the first vaccination.|Antibody seroconversion rate against receptor-binding domain antigen 29 days after each vaccination.|Change from baseline Geometric mean titre (GMT) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens|Change from baseline Geometric mean fold rise (GMFR) values for evaluation of immunogenicity for Spike protein and receptor-binding receptor domain antigens|Antibody seroconversion rate of neutralizing antibodies to SARS-CoV-2 antigen - 29 days after each vaccination|Change from baseline GMT values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2|Change from baseline GMFR values for assessment of immunogenicity based of neutralizing antibodies to SARS-CoV-2
NCT04684446 Study in Adults of AZD1222 and rAd26-S Administered as Heterologous Prime-Boost Regimen for the Prevention of COVID-19 Recruiting Phase 1|Phase 2 Sep/15/2021 Apr/08/2022
  • Alternative id - D8111C00003
  • Interventions - Biological: AZD1222|Biological: rAd26-S
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - Vitebsk Regional Clinical Hospital, Vitebsk, Belarus|Joint-Stock Company "Group of Companies Medsi", Moscow, Russian Federation|OJSC Clinical and Diagnostic Center Euromedservice, Moscow, Russian Federation|Research Site, Moscow, Russian Federation|LLC PiterClinica, Saint-Petersburg, Russian Federation|Federal State Budget Institution "Scientific and Research Institute of Flu n.a. A.A. Smorodintseva" of Ministry of Health of Russian Federation, Saint-Petersburg, Russian Federation|Federal State Budgetary Educational Institution of Higher Education " First Saint Petersburg State Medical University named after Academician I. P. Pavlov" of the Ministry of Healthcare of the Russian Federation, St. Petersburg, Russian Federation
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Prevention
  • Enrollment - 100
  • Age - 18 Years to 130 Years   (Adult, Older Adult)
  • Outcome measures - Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 neutralising antibodies 29 days post second vaccination.|Incidence of local and systemic solicited AEs for 7 days following each vaccination (Day 1 through Day 7 for first vaccination and Day 29 through Day 35 for second vaccination).|Incidence of unsolicited AEs, SAEs and AESIs through 29 days post each vaccination (ie, until Day 29 following the first vaccination and Day 57 following the second vaccination).|Incidence of SAEs and AESIs after first vaccination until study end (Day 180).|Antibody seroconversion rate (≥ 4-fold increase from baseline) against SARS-CoV-2 Spike protein|Antibody seroconversion rate (≥ 4-fold increase from baseline) against RBD antigen.|GMT and GMFR of immunogenicity against Spike and RBD antigens (MSD serology assay) at the day of vaccination (baseline), Day 15, 29 days post each vaccination and at study end (Day 180).|Antibody seroconversion rate (≥ 4-fold increase from baseline) SARS-CoV-2 neutralising antibodies 29 days post first vaccination|GMT and GMFR of immunogenicity as measured by SARS-CoV-2 neutralising antibodies at day of vaccination (baseline), Day 15, 29 days post each vaccination and at study end (Day 180).|Intracellular cytokine staining, including quantification of Th1/Th2 responses, and flow cytometry for B- and T-cell responses from day of dosing baseline to 29 days post each vaccination and until study end|A binary response, whereby a participant is defined as a COVID-19 case if their illness (virologically confirmed [RT-PCR positive] and symptomatic) occurs
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