Completed - Monday 5 Dec 2016 to Tuesday 5 Dec 2017
QP16C08 Part A, Group 1R // Study Number: mRNA-177-P101
First round human trial for a Human Respiratory Syncytial Virus (HRSV) or Respiratory Syncytial Virus (RSV) vaccine. Completing number 21 is probably the thing that has taken the longest amount of time to complete so far, with the entirety of the medial trial taking a full 12 months from start to finish.
But let’s not jump the gun, years before the trial actually started I flagged this one for completion and did my initial research into what company’s run medial trials in Brisbane, when and how often are they run and what are the requirements to be selected. Amongst all that I discovered a Brisbane based firm going by the name QPharm, which I immediately subscribed to their mailing list/social media feeds.
I was on the mailing list and social media feeds for years while trial after trial was announced, which I was either ineligible for or the restrictions were too high, e.g. no drinking for X weeks, right on the lead up to the Christmas season, or I was out of the country.
But eventually, there was a trial where I was free and available and I met all the requirements and would not cause too much difficulty in relation to the restrictions.
So I applied, provided all the details they needed and attended the physical testing to ensure I met all the medial requirements for things like blood pressure, blood sugar levels, blood and urine tests for alcohol and illicit substances.
Few days later, I got a call advising that I needed to revisit as one of my metrics was a bit off and they needed to double check. So after another round of testing, and a few more days I got a call advising that I’ve been selected to participate in the trial.
I was provided and signed all the documentation, got all the data about what the trial was for and how long it was supposed to go, the structure of a double blinded study and procedures if something goes wrong.
The Rules:
- Refrain from eating poppy seeds for a minimum of 72 hours prior to this appointment and before dosing day
- Must be using appropriate contraception for sexual intercourse up through 1 month post vaccination
- You must not consume beverages containing alcohol within 48 hours before each visit at the study site
- All analgesics and antipyretics including a daily dose of aspirin greater than 150mg, a washout of 3 days will be required before dose administration)
- Must not have donated blood or blood products within 30 days prior to dosing and duration of the study
- Must not receive any other licensed vaccines (inactivated or live vaccines within 4 weeks prior to dose administration or planned to receive any vaccine within 4 weeks from dose
- Not have used nicotine or nicotine-containing products (eg: nicotine patch) for at least 4 weeks prior to medical screening and during study
- Must not undertake strenuous activities for 48 hours before each clinic visit, including Day 1 and for the first 4 days after dosing
- Urine drug screening will be conducted during this visit and throughout the trial period. This test detects any illegal drugs you have used in the last 3 months and will exclude you from participation in this trial (e.g. marijuana, opiates, amphetamines, methamphetamines, benzodiazepines, cocaine, etc). If detected, you may also be excluded from participating in future Q-Pharm trials.
The Schedule:
I was set for “Group A1R”, with a leading cohort of 3 individuals
Monday 5 December, 2016: Dosage day, more things signed, more blood and urine tests as well as the trial drug or placebo was administered. It was an interesting process as only one person onsite was allowed to know which participants were being dosed with a placebo (25% of participants), and the randomisation was being done in the Sydney office to ensure no contamination of the data. I was also provided with a sheet to keep track of any symptoms that showed for the following 10 days and all medications.
Initial follow up visits – Tuesday 6 December, Monday 12 December and Monday 19 December. These initial visits were probably the most difficult, because of the zero alcohol limit for a minimum of 48 hours prior. Not normally an issue, however this was peak Christmas/End of Year party season with many social events lined up each weekend on the lead up to Christmas. But I took the high road and avoided alcohol during this time, in the name of science. In terms of side effects, I didn’t really experience any except for some muscle soreness for the first few days after dosing.
Next set of follow up visits - Monday 2 January, Thursday 2 February, Saturday 4 March and Friday 2 June. Only a few minor issues during this next lot of check-ups, the first being that one was on January 2 which got moved to the third due to it being a public holiday but still meant no drinking over new years eve. The only other issue was my March check-up being moved to the Monday since it was initially scheduled for a weekend. Apart from that, it was just a case of keeping track of any doctor’s visits, medications taken and their ingredients and anything unusual.
Tuesday 5 December, 2017: The final visit was only a bit longer than normal, with the full range of tests conducted, blood tests, urine, blood pressure, temperature, the full works. Then it was a bit of a chat with some of the people involved and signing some final documents before leaving. So a full 12 months to complete, but an interesting and worthwhile thing to mark off the bucket list. Being involved with something that could eventually save lives was a pretty amazing feeling, even if I only got the placebo. But no super powers at this stage, I’m starting to think comics have lied to be all this time.
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