Vaccine Related WWYD

[goldenbird]

We have an opportunity to have DS participate in a study for an infant meningococcal vaccine. If he qualifies, they would be doing this alongside all of his regular vaccines for the first 18 months and it would be through our regular group, just have these appointments take place at a different location.
We have to decide fairly quickly since he would need to start it for his 2 month check which will be in a couple weeks.

I'm not sure what I'm looking for beyond advice/anecdotes. Has anyone ever had their child participate in a research study, especially vaccine related? Or any thoughts why this may be ill advised?

I am all for vaccines and helping push development of them forward which is why I'm leaning towards doing it. The location is about 15 miles from our house each way but they compensate $100 per visit for time and travel.

[sheilathetank]

I would. I would ask how they handle it if there are any ill effects such as additional compensation if he has a reaction and you need to have additional doctors appointments/treatments because of it.

[goldenbird]

The only thing I think of is side effects from the experimental vaccine, and that's my OTT anxiety talking. But I also see it as he more likely to contract meningitis from someone 'in the wild' than to have a severe adverse reaction to this.

[gimmeaQ]

My biggest/only real concern (assuming you can swing it logistically) is how they would deal with any potential adverse affects. NOT that I think it's highly likely, but it is a possibility. I'd make sure they would take exceptional care of him if anything were to happen.

[microworm]

I work in pharma so you can guess my answer is yes. By the time they are doing clinical trials, they already have collected ample data on it's safety. sheilathetank also brings up an excellent point.

[byjove]

Is this basically the adolescent version dosed for infants? So it's not actually a brand new vaccine, right? I feel like that should help your anxiety right there if that is the case. It is already a studied, effective, commonly given vaccine. They just have to get approval and jump through hoops to start giving it to younger kids.

[Deleted]

Not my child, but my brother did the varicella one back in the day. I would do one if approached.

[chriskoo]

Is this vaccine already being used in other countries and just looking for approval in the US?

If so, that would help ease any concerns.

I had a similar decision to make when DD was 2 months old. I’m in Ontario and we were given the option of getting a ‘new’ menengitis vaccine in addition to the standard ones. It had 3 doses and wasn’t covered by insurance because it hadn’t yet been added to the province’s standard vaccination schedule. We went ahead and did it, with no noticeable side effects.

[sprinkles]

My son was diagnosed with meningitis when he was five days old. It ended up being viral, but he still had to go through the treatment for bacterial meningitis for almost a week before they got the cultures back. It was so, so horrible.

All that to say, I think participating in a trial like this is really admirable and I would do it in a heartbeat if we had another baby/the opportunity.

[thatgolfb]

Sept 14, 2018 7:19:14 GMT -6 microworm said:

I work in pharma so you can guess my answer is yes. By the time they are doing clinical trials, they already have collected ample data on it's safety. sheilathetank also brings up an excellent point.

This is what I was going to say. And yes, I would do it.

[calendula]

I would definitely do it.

[frantastic]

Sept 14, 2018 7:28:11 GMT -6 sprinkles said:

My son was diagnosed with meningitis when he was five days old. It ended up being viral, but he still had to go through the treatment for bacterial meningitis for almost a week before they got the cultures back. It was so, so horrible.

We had exactly this experience with DS2 when he was 17 days old.  Worst days of my life. 

I would do the trial without hesitation. 

ETA: I work in research administration and we do clinical trials. 

[Pizzaslut]

Sept 14, 2018 7:28:42 GMT -6 thatgolfb said:

Sept 14, 2018 7:19:14 GMT -6 microworm said:

I work in pharma so you can guess my answer is yes. By the time they are doing clinical trials, they already have collected ample data on it's safety. sheilathetank also brings up an excellent point.

This is what I was going to say. And yes, I would do it.

Well I was against but with your two opinions, my opinion has changed.

[thatgolfb]

Sept 14, 2018 7:55:43 GMT -6 Pizzaslut said:

Sept 14, 2018 7:28:42 GMT -6 thatgolfb said:

This is what I was going to say. And yes, I would do it.

Well I was against but with your two opinions, my opinion has changed.

I will say, even with how pro vax I am, I completely understand any hesitation a parent may have over their kid, especially a teeny infant, participating in something like this. 100%.

[goldenbird]

Sept 14, 2018 7:21:24 GMT -6 byjove said:

Is this basically the adolescent version dosed for infants? So it's not actually a brand new vaccine, right? I feel like that should help your anxiety right there if that is the case. It is already a studied, effective, commonly given vaccine. They just have to get approval and jump through hoops to start giving it to younger kids.

I am not sure. DS was fussing when I was on the phone with the woman. She is going to call me next week and that will be on my list of questions, as well as sheilathetank's point about expenses/care related to adverse effects.

[thankfully]

I work primarily in phase 1 clinical trials and based on my experience there are very few trials I would enroll my own child in. What is the actual purpose of the study? I could not say yes or no based on what you’ve presented. Is it approved for use elsewhere? Are they testing efficacy? What is the safety profile in the adults they have already tested it on? I am 110% pro-vax but that isn’t enough for me to say yes.

[thankfully]

Regarding treatment & follow up care, I’d expect all of that to be covered. Not in the form of extra payment, but paying the bills.

[bishopsrook]

I'm going to echo what the other pharma workers are saying. By the time it gets to clinical trial, it's been tested to quite an extent.

I would not have done the vaccine trial with my kid though because of her already existing medical stuff (it would have likely invalidated her as a candidate), but had that not been a factor, I'd have done it.

[goldenbird]

Sept 14, 2018 8:20:41 GMT -6 thankfully said:

I work primarily in phase 1 clinical trials and based on my experience there are very few trials I would enroll my own child in. What is the actual purpose of the study? I could not say yes or no based on what you’ve presented. Is it approved for use elsewhere? Are they testing efficacy? What is the safety profile in the adults they have already tested it on? I am 110% pro-vax but that isn’t enough for me to say yes.

I'm going to make note of these questions also.

[sheilathetank]

Sept 14, 2018 8:20:41 GMT -6 thankfully said:

I work primarily in phase 1 clinical trials and based on my experience there are very few trials I would enroll my own child in. What is the actual purpose of the study? I could not say yes or no based on what you’ve presented. Is it approved for use elsewhere? Are they testing efficacy? What is the safety profile in the adults they have already tested it on? I am 110% pro-vax but that isn’t enough for me to say yes.

Can you expand on why? Phase 1 trials have to happen somehow and if there aren't willing candidates then what? This is why a lot of new drugs and medical devices are trialed in poor countries first as a way to bypass an alleviate concerns, which makes me feel some type of way. 

That last sentence isn't directed at you, just at the process and people's thoughts on clinical trials in general. Like our own children are too good to subject them to it, let the poor take the bullet for us. 

[katelou]

My 2 yo is in a phase II clinical trial. I am 100% comfortable with what she’s taking (or she could be taking placebo) as it has been approved in many other countries for a long time.

I’m actually regretting it because of the follow-up. I enrolled her at 12 months and she has since turned into a pretty anxious and fearful kid who is a wreck at the pediatrician. I feel like the study visits coming up are going to unnecessarily contribute to her doctor phobia. So required follow-up is something to take into consideration too.

[thankfully]

Sept 14, 2018 8:38:39 GMT -6 sheilathetank said:

Sept 14, 2018 8:20:41 GMT -6 thankfully said:

I work primarily in phase 1 clinical trials and based on my experience there are very few trials I would enroll my own child in. What is the actual purpose of the study? I could not say yes or no based on what you’ve presented. Is it approved for use elsewhere? Are they testing efficacy? What is the safety profile in the adults they have already tested it on? I am 110% pro-vax but that isn’t enough for me to say yes.

Can you expand on why? Phase 1 trials have to happen somehow and if there aren't willing candidates then what? This is why a lot of new drugs and medical devices are trialed in poor countries first as a way to bypass an alleviate concerns, which makes me feel some type of way. 

That last sentence isn't directed at you, just at the process and people's thoughts on clinical trials in general. Like our own children are too good to subject them to it, let the poor take the bullet for us. 

It comes down to the consent piece. I work with consenting adults on a daily basis. Consent on behalf of your child is mentally much different, for me.

[lifesaverz]

Sept 14, 2018 9:55:14 GMT -6 thankfully said:

Sept 14, 2018 8:38:39 GMT -6 sheilathetank said:

Can you expand on why? Phase 1 trials have to happen somehow and if there aren't willing candidates then what? This is why a lot of new drugs and medical devices are trialed in poor countries first as a way to bypass an alleviate concerns, which makes me feel some type of way. 

That last sentence isn't directed at you, just at the process and people's thoughts on clinical trials in general. Like our own children are too good to subject them to it, let the poor take the bullet for us. 

It comes down to the consent piece. I work with consenting adults on a daily basis. Consent on behalf of your child is mentally much different, for me.

This is a good point. For me personally, I would not do it, & I think this is part of why. I would not feel comfortable doing anything medically unnecessary on an infant. I will do what is recommended & considered important & safe, but I just wouldn’t feel comfortable with the experimental piece.

[thankfully]

Just wanting to expand a little further on consent. I think a lot of people would hesitate to do a 23andme analysis for their kid. I’ve done it myself and I’m excited about the research piece, but I’m not sending my kid’s dna for analysis. In almost all of our trials we have a biobanking piece, which is a pretty open-ended consent for long term storage and genetic testing of specimens— possibly completely unrelated to the study/medication. If you’d think twice about 23andme I’d think you’d think twice about that too. It’s a lot to think about for an adult to consent, for me it’s even heavier for a kid.

[Jackaroe]

Both my kids have been vaccinated for two types of meningitis. It is part of the standard vaccinations, I can look and see which ones if you want.

[honda]

I'm surprised by how many members here are involved in clinical trials in some way.

I would do it if we were asked.

[Lormor]

Sept 14, 2018 7:27:56 GMT -6 chriskoo said:

Is this vaccine already being used in other countries and just looking for approval in the US?

...

Do you in the US not have meningitis vaccines for babies? My kids (South Africa) we’re both vaccinated as babies. It’s a new vaccine and not yet on the govt vaccination schedule, but is available on the private schedule.

[chriskoo]

Lormor was it bexaro? That’s the vaccine we were offered in Canada for DD, same situation as you. It was approved but just not on the standard schedule yet.

[Jackaroe]

I just looked at my kids vaccination schedule, they get men c and men b with their other vaccinations starting at 2 months . It is standard in U.K. And Ireland.

[thatgolfb]

I understand the logic behind kids not being able to consent, but I personally would not let that deter me. To get to this point in the study, many many safety studies already would have been done. There is, I would think, zero chance they are giving an infant a live vaccine, which IMO would be the biggest risk factor for a young infant.

If the study is successful and this becomes widespread, it could be a life saving vaccine for many future children.