Ad26.COV2.S

This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon.

Identification

Name
Ad26.COV2.S
Accession Number
DB15857
Description

Ad26.COV2.S is a lead recombinant vaccine candidate 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. This vaccine lead candidate uses Janssen’s AdVac® and PER.C6® technologies. A preclinical study in hamsters infected with SARS-COV-2 infection1 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 monkeys2 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).

Type
Biotech
Groups
Investigational
Biologic Classification
Vaccines
Recombinant
Synonyms
  • Ad26COVS1
  • JNJ-78436735
External IDs
  • Ad26.COV2.S

Pharmacology

Indication
Not Available
Contraindications & Blackbox Warnings
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Pharmacodynamics
Not Available
Mechanism of action
Not Available
Absorption
Not Available
Volume of distribution
Not Available
Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half-life
Not Available
Clearance
Not Available
Adverse Effects
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Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
Not Available

Products

Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Janssen COVID-19 VaccineSuspension50000000000 [PFU]/0.5mLIntramuscularJanssen Products, LP2021-01-04Not applicableUS flag
Additional Data Available
  • Application Number
    Application Number
    Available for Purchase

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code
    Available for Purchase

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Janssen COVID-19 VaccineAd26.COV2.S (50000000000 [PFU]/0.5mL)SuspensionIntramuscularJanssen Products, LP2021-01-04Not applicableUS flag

Categories

Drug Categories
Not Available
Classification
Not classified

Chemical Identifiers

UNII
JT2NS6183B
CAS number
Not Available

References

General References
  1. Tostanoski LH, Wegmann F, Martinot AJ, Loos C, McMahan K, Mercado NB, Yu J, Chan CN, Bondoc S, Starke CE, Nekorchuk M, Busman-Sahay K, Piedra-Mora C, Wrijil LM, Ducat S, Custers J, Atyeo C, Fischinger S, Burke JS, Feldman J, Hauser BM, Caradonna TM, Bondzie EA, Dagotto G, Gebre MS, Jacob-Dolan C, Lin Z, Mahrokhian SH, Nampanya F, Nityanandam R, Pessaint L, Porto M, Ali V, Benetiene D, Tevi K, Andersen H, Lewis MG, Schmidt AG, Lauffenburger DA, Alter G, Estes JD, Schuitemaker H, Zahn R, Barouch DH: Ad26 vaccine protects against SARS-CoV-2 severe clinical disease in hamsters. Nat Med. 2020 Sep 3. pii: 10.1038/s41591-020-1070-6. doi: 10.1038/s41591-020-1070-6. [PubMed:32884153]
  2. Mercado NB, Zahn R, Wegmann F, Loos C, Chandrashekar A, Yu J, Liu J, Peter L, McMahan K, Tostanoski LH, He X, Martinez DR, Rutten L, Bos R, van Manen D, Vellinga J, Custers J, Langedijk JP, Kwaks T, Bakkers MJG, Zuijdgeest D, Rosendahl Huber SK, Atyeo C, Fischinger S, Burke JS, Feldman J, Hauser BM, Caradonna TM, Bondzie EA, Dagotto G, Gebre MS, Hoffman E, Jacob-Dolan C, Kirilova M, Li Z, Lin Z, Mahrokhian SH, Maxfield LF, Nampanya F, Nityanandam R, Nkolola JP, Patel S, Ventura JD, Verrington K, Wan H, Pessaint L, Van Ry A, Blade K, Strasbaugh A, Cabus M, Brown R, Cook A, Zouantchangadou S, Teow E, Andersen H, Lewis MG, Cai Y, Chen B, Schmidt AG, Reeves RK, Baric RS, Lauffenburger DA, Alter G, Stoffels P, Mammen M, Van Hoof J, Schuitemaker H, Barouch DH: Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques. Nature. 2020 Jul 30. pii: 10.1038/s41586-020-2607-z. doi: 10.1038/s41586-020-2607-z. [PubMed:32731257]
  3. Precision Vaccine [Link]
  4. Johnson & Johnson Announcement [Link]
Not Available

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol2
2RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Healthy Volunteers1
1Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Healthy Volunteers1
1, 2RecruitingOtherCoronavirus Disease 2019 (COVID‑19) / Healthy Volunteers1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SuspensionIntramuscular50000000000 [PFU]/0.5mL
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Drug created on September 17, 2020 15:13 / Updated on September 18, 2020 02:47

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