J&J offers PhI/IIa data showing its single-dose vaccine can stir up sufficient immune response - Endpoints News

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Days af­ter J&J dosed the first par­tic­i­pants of its Phase III EN­SEM­BLE tri­al, the phar­ma gi­ant has de­tailed the ear­ly-stage da­ta that gave them con­fi­dence in a sin­gle-dose reg­i­men.

Test­ing two dose lev­els ei­ther as a sin­gle dose or in a two-dose sched­ule spaced by 56 days in, the sci­en­tists from Janssen, the J&J sub­sidiary de­vel­op­ing its vac­cine, re­port­ed that the low dose in­duced a sim­i­lar im­mune re­sponse as the high dose. The in­ter­im Phase I/IIa re­sults were post­ed in a preprint on medRx­iv.

More im­por­tant­ly:

A sin­gle dose of Ad26.COV2.S elicit­ed strong hu­moral re­spons­es in the vast ma­jor­i­ty of vac­cine re­cip­i­ents. S-bind­ing an­ti­body titers as mea­sured by ELISA, in­creased from base­line to Day 29 post vac­ci­na­tion in 99% of the par­tic­i­pants in co­hort 1a and 100% of the first par­tic­i­pants in co­hort 3, in­de­pen­dent of the vac­cine dose lev­el that was giv­en.

When it comes to neu­tral­iz­ing an­ti­bod­ies, 98% had de­tectable neu­tral­iz­ing an­ti­bod­ies against the wild-type virus af­ter 29 days.

The J&J sci­en­tists made note of the fact all oth­er Covid-19 vac­cines cur­rent­ly in de­vel­op­ment re­quire two dos­es, but every­one who had a neu­tral­iz­ing an­ti­body re­sponse on their can­di­date ob­tained it af­ter a sin­gle dose.

A chal­lenge study they’ve con­duct­ed in mon­keys sup­port this fund­ing, they added: Pre­vi­ous­ly dis­closed pre­clin­i­cal da­ta showed that a sin­gle dose pro­vid­ed com­plete pro­tec­tion against SARS-CoV-2 repli­ca­tion in the lung and near-com­plete pro­tec­tion against vi­ral repli­ca­tion in the nose.”

In­ter­est­ing­ly, the re­sults sug­gest­ed that old­er adults may be less like­ly to ex­pe­ri­ence side ef­fects on the vac­cine.

“Al­though the safe­ty da­ta in this in­ter­im re­port re­main blind­ed, the over­all oc­cur­rence in­de­pen­dent of dose lev­el of so­licit­ed sys­temic AEs of 64% with a 19% fever rate (5% grade 3) in adults aged 18 to 55 (Co­hort 1a and 1b) stands in con­trast to the so­licit­ed sys­temic AEs of 36% with a 4% fever rate (0% grade 3), found in the par­tic­i­pants ≥ 65 years of age,” the re­searchers wrote.

Lever­ag­ing a re­com­bi­nant ver­sion of ade­n­ovirus serotype 26 (Ad26) that can’t repli­cate as the vec­tor, J&J’s Ad26.COV2.S con­sists of a trans­gene cas­sette en­cod­ing a pre­fu­sion sta­bi­lized SARS-CoV-2 spike pro­tein, de­rived from the first clin­i­cal iso­late of the Wuhan strain.

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J&J offers PhI/IIa data showing its single-dose vaccine can stir up sufficient immune response - Endpoints News
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