Janssen vaccine trial thread

[BobsDouble]

I thought it might be nice to have thread for anyone doing the Janssen vaccine trial. I’ve been enjoying reading the Novavax trial thread and seeing what might be in store for those of us doing this trial.

I’m due to have my second dose of vaccine/placebo next week.

I’ll be very interested to find out how many people have already been unblinded. I’m 48 and was definitely one of the youngest in my group when I went for my first appointment and vaccine. I suspect many of the others on the trial would have already have been offered a Pfizer or AZ vaccine.

No - nothing at all.

Got one a few days ago that was C&Ped from the NIHR website.

In short - it says they're working on a solution to link the test d/b to the NHS d/b so that the NHS will recognise our jabs as valid jabs, and we will be able to get passports/certificates or whatever.
But it's slow going.

I gather they've done it.
The NHS app will now show your Jansen vaccine 😀

We will get a third vaccine?

I was wondering the same thing. I'm eligible as over 50 (I'm 60).

My trial centre said they won’t be giving a third vaccine, so we should just take whatever is offered as and when it is offered,

Won't that invalidate the trial?

At the beginning of the trial they said we would never be disadvantaged by being on the trial. They've already had to alter the trial by unblinding us because the licensed vaccines were ruled quicker than anyone could have imagined, so maybe they'll adapt it again and turn it into a three vaccine trial.

On the other hand, we're being tested regularly for antibodies, so it could be that we don't need the third vaccine.

Here's the update I received today re a third "booster" vaccine. Apparently the Jansen vax is so good we don't need a third booster . The second Jansen vax was our booster. People receiving Jansen in the Community only need one jab.

As announced on 21 Sep 2021, new data reinforcing the strong and long-lasting protection of the Janssen COVID-19 vaccine in prevention of severe/critical COVID-19 infection. New data also showed that protection against COVID-19 increases when a second dose of the Janssen COVID-19 vaccine is administered. The safety profile of the vaccine remained consistent and the vaccine was generally well tolerated when administered as a second dose.

It is important to highlight, that the large real-world evidence data and data from the Phase 3 studies confirm that the single-dose Janssen COVID-19 vaccine also provides strong and long-lasting protection against COVID-19-related hospitalizations. The Phase 3 ENSEMBLE2 study showed that the second dose of the Janssen COVID-19 vaccine given 56 days after the first provided: - increased protection as compared to the single dose (100 percent protection (CI, 33%-100%) against severe/critical COVID-19 – at least 14 days post-final vaccination; - 75 percent protection against symptomatic (moderate to severe/critical) COVID-19 globally (CI, 55%-87%); - 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%). - When a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. All rises were irrespective of age.

At this time, participants who received two doses of Ad26COV2.S will not be offered an additional dose (third dose) of Ad26COV2.S in the ENSEMBLE2 study. In fact, the Janssen vaccine was authorized in a single-dose regimen. Those who received 2 doses have received technically already the “booster” for the single dose.

• All trial participants are encouraged to stay in the study.
• Trial participants that choose to receive the booster vaccination outside of the study are invited to stay in the study.
• Administration of a third dose of Ad26.COV2.S is currently not allowed per protocol in the ENSEMBLE2 study.
• Trial participants should be informed that if they choose to receive the booster vaccination offered through the national vaccination program, that there is no safety information available to date for mixed vaccination schedules against COVID-19 infection

It's weird, because on the Jansen trial Facebook group someone was saying that the one dose people will be offered a second dose and, I think, the 2 dose people will be offered an NHS booster? It's seems she had had a different email from the trial!

They seem to say different things at different trial sites!

I don't live in the UK. Jansen has been used here for a while. Many of my friends have had it. No noticeable side effects

I never knew there was a Facebook group. I'll have

Oops!

I'll have a look for it.

Yes - there's about a 100 or so of us in fb group. Some from the uk and some from the us. Just search for ensemble2 and I think it should come up.

I'm off to look for the FB group too! See you there

Last month, the company announced that a second dosee_, given two months after the first, increased the vaccine’s effectiveness against symptomatic Covid-19 by about 22 percentage points, to 94 percent. The firm also said two shots were 100 percent effective against severe disease, although that estimate was less conclusive.

https://www.nytimes.com/2021/10/04/us/politics/johnson-vaccine-booster-coronavirus.html?referringSource=articleShare&fbclid=IwAR3c6ejY98ZTPwmzcl2jT00WpZOij4k5Odj3zFFFIfnfCrmvC661dGHRw

It’s 4am (almost) and I feel awful!

Two jabs of the Jansen, and nothing. So much so I thought I’d had the placebo.
One shot of Pfizer today has floored me. I was fine when we were messaging earlier, but now I feel like death warmed up - v warm in between being v cold 😀
Also arm v sore, and it’s my sleeping side 😪