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A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plu

2016-10-18 02:08:21 | BioPortfolio

Summary

The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.

Description

This is a randomized (study medication assigned by chance), double-blind (neither physician nor participant knows the treatment received), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each treatment group will be treated at the same time), multicenter (more than one clinical site) study in healthy human immunodeficiency virus (HIV)-uninfected adults. The study will be conducted in 3 phases: a 6-week screening period; a 48-week vaccination period; and a follow-up period to the final visit at Week 72. The approximate duration of the study will be approximately 78 weeks. Participants safety will be monitored throughout the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Healthy

Intervention

Ad26.Mos4.HIV, Clade C gp140 plus adjuvant, Clade C gp140/Mosaic gp140 plus adjuvant, Placebo

Location

Birmingham
Alabama
United States

Status

Not yet recruiting

Source

Janssen Vaccines & Prevention B.V.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-18T02:08:21-0400

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Medical and Biotech [MESH] Definitions

Transforming glycoprotein coded by the fms oncogene from the Susan McDonough strain of feline sarcoma virus (SM-FeSV). The oncogene protein v-fms lacks sequences, which, in the highly homologous proto-oncogene protein c-fms (CSF-1 receptor), normally serve to regulate its tyrosine kinase activity. The missing sequences in v-fms mimic the effect of ligand and lead to constitutive cell growth. The protein gp120(v-fms) is post-translationally modified to generate gp140(v-fms).

An order of the Lamiidae clade. Lamiales is one of the largest orders of flowering plants and includes pot-herbs in the mint family (MINT; SAGE; OREGANO; BASIL); SESAME, foxgloves; SNAPDRAGONS; and the olive family.

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Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

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An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...


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