The drug in clinical trials has shown up to 100% efficacy with side effects comparable to other vaccines.
The anti-coronavirus vaccine candidate Ad26.COV2.S from Johnson & Johnson (developed by its subsidiary, Janssen) has successfully completed phase I / IIa clinical trials.
It is noted that the basis of the drug is a non-replicating vector from human adenovirus type 26 (Ad26), the genome of which has been modified to produce the S-protein SARS-CoV-2. In other words, the creators took a virus of one of the “colds” harmless to humans, deprived it of the ability to multiply in cells, and armed them with coronavirus spike proteins – to “irritate” the immune system and train it to fight the real coronavirus.
The study randomly assigned 805 healthy adult participants 18-55 years old (cohort # 1) and> 65 years old (cohort # 3). They received a dose of 5 x 1010 viral particles (low dose) or 1 x 1011 (high) per ml, or placebo. Both single and double-dose immunizations were used: the safety and reactogenicity (side effects) of each regimen were verified.
Cohort 2 collects longer term data to compare one- and two-dose regimens; the test results will be published later.
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The most common “adverse events” were found to be typical: pain at the injection site, fatigue, headache, myalgia, and fever. “Side effects” were less common in the elderly cohort, in the low dose vaccine, and after the second dose. Overall, the reactogenicity of Ad26.COV2.S was comparable to other similar vaccines, with a second dose less than Pfizer / BioNTech and Moderna.
By the end of the first month after the first dose, more than 90% of those vaccinated had neutralizing antibodies, 100% by the end of the second month, and continued to grow. This effect was observed regardless of dose or age. The second dose increased the amount of antibodies up to three times.
As for the T-cell response, two weeks later, CD4 + lymphocytes were found in 76-83% of people from cohort No. 1 and in 60-67% of the elderly. There is a clear list in T-cells of the Th1 type, which is a positive point, since withdrawal into the Th2 response leads to a possible increase in symptoms.
Clinical trials of the reporting phase started on July 22, and phase III (final) began on September 7 on 60,000 volunteers with a single dose and on November 15 on 30,000 in a two-dose regimen with an interval of 57 days.
The research results are published in the New England Journal of Medicine.