Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)

Altimmune

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: AdCOVID; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04679909

ALT-501-101

Details and patient eligibility

About

A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.

Enrollment: 92 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women ages 18 to 55 years, inclusive
• Good general health status
• Screening laboratory results within institutional normal range or Grade 1 abnormality if the Investigator documents clinical insignificance. Grade 2 laboratories may be permissible if considered not clinically significant by the investigator.
• For women who have not been surgically sterilized or who do not have laboratory confirmation of postmenopausal status, negative pregnancy test
• Willingness to practice a highly effective method of contraception
• Ability and willingness to comply with all aspects of the study, including nasopharyngeal swabs and blood and urine samples, through the entire study period

Exclusion criteria

• Subjects at increased risk of exposure to SARS-CoV-2, including healthcare workers, emergency response personnel, and those with known contact with COVID-19 patients
• Pregnant or lactating women or planning to conceive a child during the next 3 months
• Body mass index (BMI) > 30.0 kg/m2
• Acute COVID-19, a positive test result for SARS-CoV2 infection, a positive SARS-CoV-2 serology for prior SARS-CoV-2 infection at screening, or exposure within 14 days to an individual with acute COVID-19
• An acute respiratory illness
• Positive result for HIV, hepatitis B virus, or hepatitis C virus at screening
• Chronic or current cigarette smoking
• Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 8 patient groups, including a placebo group

Single Low Dose AdCOVID

Experimental group

Treatment:

Biological: AdCOVID

Single Medium Dose AdCOVID

Experimental group

Treatment:

Biological: AdCOVID

Single High Dose AdCOVID

Experimental group

Treatment:

Biological: AdCOVID

Two Low Doses AdCOVID

Experimental group

Treatment:

Biological: AdCOVID

Two Medium Doses AdCOVID

Experimental group

Treatment:

Biological: AdCOVID

Two High Doses AdCOVID

Experimental group

Treatment:

Biological: AdCOVID

Single Dose Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Two Dose Placebo

Placebo Comparator group

Treatment:

Other: Placebo